BLISTEX ADVANCED CARE (BLISTEX MEDICATED BALM, BLISTEX COMPLETE MOISTURE, BLISTEX FIVE STAR LIP BALM - BROAD SPECTRUM, BLISTEX S

United States - English - NLM (National Library of Medicine)

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Active ingredient:
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)
Available from:
Blistex Inc
Prescription type:
OTC DRUG
Therapeutic indications:
- temporarily protects and helps relieve chapped or cracked lips - helps prevent sunburn - if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun - temporarily protects and helps relieve chapped or cracked lips - helps prevent sunburn
Authorization status:
OTC monograph final
Authorization number:
10157-9905-1

BLISTEX ADVANCED CARE (BLISTEX MEDICATED BALM, BLISTEX COMPLETE

MOISTURE, BLISTEX FIVE STAR LIP BALM - BROAD SPECTRUM, BLISTEX

SUPERFRUIT SOOTHER)- dimethicone, octinoxate, octisalate, avobenzone, and homosalate

Blistex Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Blis tex

Advanced Care (Blistex Medicated Balm, Blistex Complete Moisture

, Blistex Five Star

Lip Balm - Broad Spectrum, Blistex Superfruit Soother

)

FIVE STAR Lip Protection

Drug Facts

Active ingredients

Purpose

Avobenzone 3.0% (w/w)

Sunscreen

Dimethicone 2.0% (w/w)

Lip protectant

Homosalate 10.0% (w/w)

Sunscreen

Octinoxate 7.5% (w/w)

Sunscreen

Octisalate 5.0% (w/w)

Sunscreen

Us es

temporarily protects and helps relieve chapped or cracked lips

helps prevent sunburn

if used as directed with other sun protection measures (see Directions), decreases the risk of skin

cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs

When using this product keep out of eyes.

Rinse with water to remove.

Keep out of reach of children. If swallowed,get medical help or contact a Poison Control Center right

away.

Directions

apply liberally 15 minutes before sun exposure

reapply:

after 80 minutes of swimming or sweating

immediately after towel drying

at least every 2 hours

children under 6 months of age: Ask a doctor

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early

skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15

or higher and other sun protection measures including:

®

®

®

®

limit time in the sun, especially from 10 a.m.-2 p.m.

wear long sleeve shirts, pants, hats, and sunglasses

Other information

protect the product in this container from excessive heat and direct sun

Inactive ingredients

bis-diglyceryl polyacyladipate-2, bis-stearyl dimethicone, calendula officinalis flower extract,

carthamus tinctorius (safflower) seed oil, cetyl dimethicone, citric acid, euphorbia cerifera (candelilla)

wax, flavor, helianthus annuus (sunflower) seed oil, microcrystalline wax, myristyl myristate,

octyldodecanol, ozokerite, panthenol, phenoxyethanol, sorbic acid, stearyl behenate, sucralose,

tetrahexyldecyl ascorbate, tocopheryl acetate, triticum vulgare (wheat) germ oil

COMPLETE MOISTURE SPF 15 MEDICATED BALM SPF 15 SUPERFRUIT SOOTHER

SPF 15

Drug Facts

Active ingredients

Purpose

Dimethicone 2.0% (w/w)

Lip protectant

Octinoxate 6.6% (w/w)

Sunscreen

Octisalate 4.4% (w/w)

Sunscreen

Us es

temporarily protects and helps relieve chapped or cracked lips

helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been

shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right

away.

Directions

apply liberally 15 minutes before sun exposure

reapply at least every 2 hours

use a water resistant sunscreen if swimming or sweating

children under 6 months of age: Ask a doctor

Other information

protect the product in this container from excessive heat and direct sun

®

®

protect the product in this container from excessive heat and direct sun

COMPLETE MOISTURE Inactive ingredients

behenoyl stearic acid, caprylic/capric triglyceride, cholesteryl/behenyl/octyldodecyl lauroyl glutamate,

diethylhexyl adipate, ethylhexyl palmitate, ethylhexyl stearate, flavor, glycerin, hydrogenated

phosphatidylcholine, jojoba esters, microcrystalline wax, ozokerite, panthenol, petrolatum,

phenoxyethanol, purified water, sodium borate, sodium saccharin, squalane

MEDICATED BALM Inactive ingredients

beeswax, camphor, cetyl alcohol, cetyl palmitate, euphorbia cerifera (candelilla) wax, flavor, isopropyl

myristate, lanolin, lanolin oil, menthol, methyl salicylate, mineral oil, ozokerite, paraffin, petrolatum,

phenoxyethanol, polybutene, red 6 lake, theobroma cacao (cocoa) seed butter, titanium dioxide

SUPERFRUIT SOOTHER Inactive ingredients

beeswax, caprylic/capric triglyceride, cetyl alcohol, cetyl palmitate, euphorbia cerifera (candelilla)

wax, euterpe oleracea (acai) fruit extract, flavor, isopropyl myristate, lanolin, lanolin oil,

menthoxypropanediol, mineral oil, ozokerite, paraffin, petrolatum, phenoxyethanol, polybutene, rubus

chamaemorus (cloudberry) fruit extract, saccharin, tetrahexyldecyl ascorbate, theobroma cacao (cocoa)

seed butter, tocopheryl acetate

PRINCIPAL DISPLAY PANEL - Kit Carton

Blistex

LIP PROTECTANT/SUNSCREEN

ADVANCED CARE

VALUE PACK

Dial Up Your Lip Care

Buy 3 Upgrades

Power

Protection

Ultra

Moisturizing

Super

Soothing

Get 1

Classic

FREE

4 Sticks Net Wt. 0.15 oz. (4.25 g) ea.

BLISTEX ADVANCED CARE (BLISTEX MEDICATED BALM, BLISTEX

COMPLETE MOISTURE, BLISTEX FIVE STAR LIP BALM - BROAD

SPECTRUM, BLISTEX SUPERFRUIT SOOTHER)

dimethicone, octinoxate, octisalate, avobenzone, and homosalate kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:10 157-9 9 0 5

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:10 157-9 9 0 5-1

1 in 1 CARTON

0 8 /26 /20 19

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

1 CYLINDER

4.25 g

Pa rt 2

1 CYLINDER

4.25 g

Pa rt 3

1 CYLINDER

4.25 g

Pa rt 4

1 CYLINDER

4.25 g

Part 1 of 4

BLISTEX MEDICATED LIP BALM

dimethicone, octinoxate, and octisalate stick

Product Information

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DIMETHICO NE (UNII: 9 2RU3N3Y1O) (DIMETHICONE - UNII:9 2RU3N3Y1O)

DIMETHICONE

2 g in 10 0 g

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

6 .6 g in 10 0 g

O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

OCTISALATE

4.4 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

MINERAL O IL (UNII: T5L8 T28 FGP)

PETRO LATUM (UNII: 4T6 H12BN9 U)

CERESIN (UNII: Q1LS2UJO3A)

CANDELILLA WAX (UNII: WL0 328 HX19 )

LANO LIN O IL (UNII: OVV5IIJ58 F)

YELLO W WAX (UNII: 2ZA36 H0 S2V)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

LANO LIN (UNII: 7EV6 5EAW6 H)

PO LYBUTENE ( 14 0 0 MW) (UNII: 1NA5AO9 GH7)

CETYL PALMITATE (UNII: 5ZA2S6 B0 8 X)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

PARAFFIN (UNII: I9 O0 E3H2ZE)

CO CO A BUTTER (UNII: 512OYT1CRR)

MENTHO L, UNSPECIFIED FO RM (UNII: L7T10 EIP3A)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

.ALPHA.,.ALPHA.-DIBRO MO -D-CAMPHO R (UNII: F8 9 Z8 SAG3O)

METHYL SALICYLATE (UNII: LAV5U50 22Y)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

D&C RED NO . 6 (UNII: 48 1744AI4O)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

4.25 g in 1 CYLINDER; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt347

0 8 /26 /20 19

Part 2 of 4

BLISTEX COMPLETE MOISTURE

dimethicone, octinoxate, and octisalate stick

Product Information

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DIMETHICO NE (UNII: 9 2RU3N3Y1O) (DIMETHICONE - UNII:9 2RU3N3Y1O)

DIMETHICONE

2 g in 10 0 g

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

6 .6 g in 10 0 g

O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

OCTISALATE

4.4 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

ETHYLHEXYL PALMITATE (UNII: 28 6 59 9 330 9 )

ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)

DIETHYLHEXYL ADIPATE (UNII: MBY1SL9 21L)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

MICRO CRYSTALLINE WAX (UNII: XOF59 7Q3KY)

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

HYDRO GENATED SO YBEAN LECITHIN (UNII: H110 9 Z9 J4N)

PETRO LATUM (UNII: 4T6 H12BN9 U)

CERESIN (UNII: Q1LS2UJO3A)

7 -BEHENO YLSTEARIC ACID (UNII: P2T8 BLD8 3C)

HYDRO GENATED JO JO BA O IL, RANDO MIZED (UNII: Q47ST0 2F58 )

SO DIUM BO RATE (UNII: 9 1MBZ8 H3QO)

PANTHENO L (UNII: WV9 CM0 O6 7Z)

SQ UALANE (UNII: GW8 9 575KF9 )

CHO LESTERYL/BEHENYL/O CTYLDO DECYL LAURO YL GLUTAMATE (UNII: 0 7PS46 3G0 H)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

4.25 g in 1 CYLINDER; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt352

0 8 /26 /20 19

Part 3 of 4

BLISTEX FIVE STAR LIP PROTECTION BROAD SPECTRUM

dimethicone, avobenzone, homosalate, octinoxate, and octisalate stick

Product Information

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Dimethico ne (UNII: 9 2RU3N3Y1O) (Dimethico ne - UNII:9 2RU3N3Y1O)

Dime thic o ne

2 g in 10 0 g

Avo benzo ne (UNII: G6 3QQF2NOX) (Avo benzo ne - UNII:G6 3QQF2NOX)

Avo be nz o ne

3 g in 10 0 g

Ho mo sa la te (UNII: V0 6 SV4M9 5S) (Ho mo salate - UNII:V0 6 SV4M9 5S)

Ho mo sa la te

10 g in 10 0 g

O ctino xa te (UNII: 4Y5P7MUD51) (Octino xate - UNII:4Y5P7MUD51)

O c tino xa te

7.5 g in 10 0 g

O ctisa la te (UNII: 4X49 Y0 59 6 W) (Octisalate - UNII:4X49 Y0 59 6 W)

O c tisa la te

5 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

Micro crysta lline Wa x (UNII: XOF59 7Q3KY)

O ctyldo deca no l (UNII: 46 1N1O6 14Y)

Ceresin (UNII: Q1LS2UJO3A)

Myristyl Myrista te (UNII: 40 42ZC0 0 DY)

Stea ryl Behena te (UNII: A6 8 S9 UI39 D)

CETYL DIMETHICO NE 150 (UNII: 5L6 9 4Y0 T22)

STEARYL DIMETHICO NE ( 4 0 0 MPA.S AT 50 C) (UNII: R327X19 7HY)

Bis-Dig lyceryl Po lya cyla dipa te-2 (UNII: 6 L246 LAM9 T)

CANDELILLA WAX (UNII: WL0 328 HX19 )

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

TETRAHEXYLDECYL ASCO RBATE (UNII: 9 LBV3F0 7AZ)

Pheno xyetha no l (UNII: HIE49 2ZZ3T)

SUNFLO WER O IL (UNII: 3W1JG79 5YI)

CALENDULA O FFICINALIS FLO WER (UNII: P0 M7O4Y7YD)

WHEAT GERM O IL (UNII: 14C9 7E6 8 0 P)

SAFFLO WER O IL (UNII: 6 5UEH26 2IS)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

SO RBIC ACID (UNII: X0 45WJ9 8 9 B)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

PANTHENO L (UNII: WV9 CM0 O6 7Z)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

4.25 g in 1 CYLINDER; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt347

0 8 /26 /20 19

Part 4 of 4

BLISTEX SUPERFRUIT SOOTHER

dimethicone, octinoxate, and octisalate stick

Product Information

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DIMETHICO NE (UNII: 9 2RU3N3Y1O) (DIMETHICONE - UNII:9 2RU3N3Y1O)

DIMETHICONE

2 g in 10 0 g

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

6 .6 g in 10 0 g

O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

OCTISALATE

4.4 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

MINERAL O IL (UNII: T5L8 T28 FGP)

PETRO LATUM (UNII: 4T6 H12BN9 U)

LANO LIN O IL (UNII: OVV5IIJ58 F)

YELLO W WAX (UNII: 2ZA36 H0 S2V)

CERESIN (UNII: Q1LS2UJO3A)

PO LYBUTENE ( 14 0 0 MW) (UNII: 1NA5AO9 GH7)

CANDELILLA WAX (UNII: WL0 328 HX19 )

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

LANO LIN (UNII: 7EV6 5EAW6 H)

CETYL PALMITATE (UNII: 5ZA2S6 B0 8 X)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

ACAI (UNII: 46 AM2VJ0 AW)

RUBUS CHAMAEMO RUS FRUIT (UNII: 74CW8 G72Q6 )

PARAFFIN (UNII: I9 O0 E3H2ZE)

CO CO A BUTTER (UNII: 512OYT1CRR)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

3 -( ( L-MENTHYL) O XY) PRO PANE-1,2 -DIO L (UNII: KD6 TZ2QICH)

SACCHARIN (UNII: FST46 7XS7D)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

TETRAHEXYLDECYL ASCO RBATE (UNII: 9 LBV3F0 7AZ)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

4.25 g in 1 CYLINDER; Type 0 : No t a Co mbinatio n Pro duct

Blistex Inc

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt347

0 8 /26 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt347

0 8 /26 /20 19

Labeler -

Blistex Inc (005126354)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Blistex Inc

0 0 5126 354

MANUFACTURE(10 157-9 9 0 5)

Revised: 8/2019

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