TEA BLEND SAMPLES JAFRA- avobenzone, octinoxate, octisalate

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

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Active ingredient:
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)
Available from:
JAFRA COSMETICS INTERNATIONAL
Prescription type:
OTC DRUG
Authorization status:
OTC monograph final
Authorization number:
68828-119-01, 68828-120-01

TEA BLEND SAMPLES JAFRA- avobenzone, octinoxate, octisalate

JAFRA COSMETICS INTERNATIONAL

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.

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Tea Blend Kit

Active ingredients purpose

Avobenzone 2.5% Sunscreen

Octinoxate 7.5% Sunscreen

Octisalate 5% Sunscreen

Us es

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.

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

Stop use and ask a doctor if rash occurs.

Warnings

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

Directions

apply liberally 15 minutes before sun exposure

use a water resistant sunscreen if swimming or sweating

reapply at least every 2 hours

children under 6 months 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.

Inactive ingredients

Water/Aqua, Polyglyceryl-3 Methylglucose Distearate, polyacrylamide, C13-14 Isoparaffin, Laureth-7,

Glycerin, Glyceryl Stearate, Saccharide Isomerate, Fragrance/Parfum, Carica Papaya Extract,

Glycyrrhiza Glabra (Licorice) Extract, Panthenol, Tocopheryl Acetate. Camellia Sinensis Leaf Extract,

Trisodium EDTA, Ethylhexylglycerin, Methylisothiazolinone.

Tea Blend

Tester

Contains: 3 samples

1 Daily Moisturizer Broad Spectrum SPF 15/1 Nightly Moisturizer/ 1 Cleanser + Toner

Cont. Net. 22,5 ml .76 Fl Oz (US)

TEA BLEND SAMPLES JAFRA

avobenzone, octinoxate, octisalate kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 8 28 -119

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 8 28 -119 -0 1

1 in 1 KIT; Type 0 : No t a Co mbinatio n Pro duct

0 1/21/20 13

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

1 TUBE

7.5 mL

Pa rt 2

1 TUBE

7.5 mL

Pa rt 3

1 TUBE

7.5 mL

Part 1 of 3

DAILY MOISTURIZER BROAD SPECTRUM SPF 15 JAFRA

avobenzone, octinoxate, octisalate cream

Product Information

Ite m Code (Source )

NDC:6 8 8 28 -120

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

AVO BENZO NE (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX)

AVOBENZONE

2.5 g in 10 0 mL

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

OCTINOXATE

7.5 g in 10 0 mL

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

OCTISALATE

5 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

PO LYACRYLAMIDE ( 150 0 MW) (UNII: 5D6 TC4BRWV)

C13 -14 ISO PARAFFIN (UNII: E4F12ROE70 )

LAURETH-7 (UNII: Z9 5S6 G8 20 1)

GLYCERIN (UNII: PDC6 A3C0 OX)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

SACCHARIDE ISO MERATE (UNII: W8 K377W9 8 I)

LICO RICE (UNII: 6 1ZBX548 8 3)

PANTHENO L (UNII: WV9 CM0 O6 7Z)

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

GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )

EDETATE TRISO DIUM (UNII: 420 IP9 21MB)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

METHYLISO THIAZO LINO NE (UNII: 229 D0 E1QFA)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 8 28 -120 -0 1

7.5 mL in 1 TUBE; 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 mo no graph final

pa rt352

0 1/18 /20 13

Part 2 of 3

CLEANSER AND TONER JAFRA

body and hand (excluding shaving preparations)

Product Information

Other Ingredients

Ingredient Kind

Ingredient Name

Quantity

INGR

WATER (UNII: 0 59 QF0 KO0 R)

INGR

SO DIUM CO CO YL GLYCINATE (UNII: XLU9 KH0 3XM)

INGR

SO DIUM LAURO YL O AT AMINO ACIDS (UNII: FSW2K9 B9 N5)

INGR

SO DIUM C14 -16 O LEFIN SULFO NATE (UNII: O9 W3D3YF5U)

INGR

CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)

INGR

PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8 L4OOQ76 AM)

INGR

PEG-8 DIMETHICO NE (UNII: GIA7T76 4OD)

INGR

SACCHARIDE ISO MERATE (UNII: W8 K377W9 8 I)

INGR

DMDM HYDANTO IN (UNII: BYR0 546 TOW)

INGR

IO DO PRO PYNYL BUTYLCARBAMATE (UNII: 6 0 3P14DHEB)

INGR

ALLANTO IN (UNII: 344S277G0 Z)

INGR

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

INGR

GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )

INGR

PAPAYA (UNII: KU9 4FIY6 JB)

INGR

LICO RICE (UNII: 6 1ZBX548 8 3)

INGR

EDETATE SO DIUM (UNII: MP1J8 420 LU)

INGR

PANTHENO L (UNII: WV9 CM0 O6 7Z)

INGR

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

INGR

HAMAMELIS VIRGINIANA TO P (UNII: UDA30 A2JJY)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

7.5 mL in 1 TUBE; 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

Co sme tic

0 1/18 /20 13

Part 3 of 3

NIGHTLY MOISTURIZER JAFRA

face and neck (excluding shaving preparations)

Product Information

Other Ingredients

Ingredient Kind

Ingredient Name

Quantity

INGR

WATER (UNII: 0 59 QF0 KO0 R)

INGR

C10 -18 TRIGLYCERIDES (UNII: 43AGM4PHPI)

INGR

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

INGR

GLYCERIN (UNII: PDC6 A3C0 OX)

INGR

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

INGR

SHEA BUTTER (UNII: K49 155WL9 Y)

INGR

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

INGR

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

INGR

SO DIUM STEARO YL LACTYLATE (UNII: IN9 9 IT31LN)

INGR

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

INGR

CARBO XYMETHYLCELLULO SE SO DIUM (UNII: K6 79 OBS311)

INGR

SACCHARIDE ISO MERATE (UNII: W8 K377W9 8 I)

INGR

PAPAYA (UNII: KU9 4FIY6 JB)

INGR

LICO RICE (UNII: 6 1ZBX548 8 3)

INGR

DMDM HYDANTO IN (UNII: BYR0 546 TOW)

INGR

VERBENA O FFICINALIS (UNII: QT8 A71T9 BM)

INGR

XANTHAN GUM (UNII: TTV12P4NEE)

INGR

PANTHENO L (UNII: WV9 CM0 O6 7Z)

INGR

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

INGR

GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )

JAFRA COSMETICS INTERNATIONAL

INGR

EDETATE TRISO DIUM (UNII: 420 IP9 21MB)

INGR

PEG-4 LAURATE (UNII: AYF4VM3N1Z)

INGR

IO DO PRO PYNYL BUTYLCARBAMATE (UNII: 6 0 3P14DHEB)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

7.5 mL in 1 TUBE; 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

Co sme tic

0 1/21/20 13

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt352

0 1/18 /20 13

Labeler -

JAFRA COSMET ICS INT ERNAT IONAL (041676479)

Registrant -

JAFRA COSMET ICS INT ERNAT IONAL (041676479)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Jafra Manufacturing, S.A. de C.V.

8 147320 6 1

manufacture(6 8 8 28 -119 , 6 8 8 28 -120 )

Revised: 5/2019

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