BLISTEX ULTRA RICH HYDRATION

Main information

  • Trade name:
  • BLISTEX ULTRA RICH HYDRATION- octinoxate, oxybenzone, and dimethicone stick
  • Composition:
  • Octinoxate 6.8 g in 100 g
  • Administration route:
  • TOPICAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BLISTEX  ULTRA RICH HYDRATION- octinoxate, oxybenzone, and dimethicone stick
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • - temporarily protects and helps relieve chapped or cracked lips - helps prevent sunburn

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Authorization number:
  • 10157-8015-1
  • Last update:
  • 30-05-2019

Summary of Product characteristics: dosage, interactions, side effects

BLISTEX ULTRA RICH HYDRATION- octinoxate, oxybenzone, and dimethicone stick

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

Ultra-Rich Hydration

Drug Facts

Active ingredients

Purpose

Dimethicone 2.0% (w/w)

Lip protectant

Octinoxate 6.8% (w/w)

Sunscreen

Oxybenzone 3.0% (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 from excessive heat and direct sun

Inactive ingredients

aloe barbadensis leaf extract, alumina, arachidyl alcohol, arachidyl glucoside, beeswax, behenyl

alcohol, bis-diglyceryl polyacyladipate-2, blue 1 lake, butyrospermum parkii (shea butter), ceresin,

cetyl dimethicone, cetyl palmitate, chamomilla recutita (matricaria) flower extract, flavors, helianthus

annuus (sunflower) seed oil, hydrogenated castor oil, hydrogenated polyisobutene, isopropyl myristate,

®

isostearoyl hydrolyzed silk, jojoba esters, microcrystalline wax, olea europaea (olive) fruit oil,

paraffin, pentaerythrityl tetraethylhexanoate, petrolatum, phenoxyethanol, phenyl trimethicone,

polyhydroxystearic acid, saccharin, silica, theobroma cacao (cocoa) seed butter, titanium dioxide,

tocopheryl acetate, triticum vulgare (wheat) germ oil

PRINCIPAL DISPLAY PANEL - 3.69 g Cylinder Blister Pack

NDC 10157-8015-1

Blis tex

LIP PROTECTANT/SUNSCREEN

ULTRA-RICH

HYDRATION

NEW!

Dual-Layer Balm

INNER: Deeply Hydrates With

80% Moisturizers

OUTER: Smoothes & Seals

With Lush Protectants

SPF 15

NET WT. .13 oz (3.69g)

BLISTEX ULTRA RICH HYDRATION

octinoxate, oxybenzone, and dimethicone stick

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:10 157-8 0 15

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

O c tino xa te

6 .8 g in 10 0 g

O xybenzo ne (UNII: 9 5OOS7VE0 Y) (Oxybenzo ne - UNII:9 5OOS7VE0 Y)

O xybe nz o ne

3 g in 10 0 g

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

Dime thic o ne

2 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

yello w wa x (UNII: 2ZA36 H0 S2V)

PENTAERYTHRITYL TETRAETHYLHEXANO ATE (UNII: XJ70 52W8 9 7)

PETRO LATUM (UNII: 4T6 H12BN9 U)

PARAFFIN (UNII: I9 O0 E3H2ZE)

HYDRO GENATED CASTO R O IL (UNII: ZF9 4AP8 MEY)

micro crysta lline wa x (UNII: XOF59 7Q3KY)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

SHEA BUTTER (UNII: K49 155WL9 Y)

ALUMINUM O XIDE (UNII: LMI26 O6 9 33)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CETYL PALMITATE (UNII: 5ZA2S6 B0 8 X)

ARACHIDYL ALCO HO L (UNII: 1QR1QRA9 BU)

DO CO SANO L (UNII: 9 G1OE216 XY)

ARACHIDYL GLUCO SIDE (UNII: 6 JVW35JOOJ)

O LIVE O IL (UNII: 6 UYK2W1W1E)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

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

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

PHENYL TRIMETHICO NE (UNII: DR0 K5NOJ4R)

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

CHAMO MILE (UNII: FGL36 8 5T2X)

ceresin (UNII: Q1LS2UJO3A)

CO CO A BUTTER (UNII: 512OYT1CRR)

SACCHARIN (UNII: FST46 7XS7D)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

Packag ing

Blistex Inc.

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:10 157-8 0 15-1

1 in 1 BLISTER PACK

1

3.6 9 g in 1 CYLINDER

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 5/30 /20 14

Labeler -

Blistex Inc. (005126354)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Blistex Inc.

0 0 5126 354

MANUFACTURE(10 157-8 0 15)

Revised: 4/2014