DEFY TIME PROTECTOR MOISTURIZER BROAD SPECTRUM SPF 15 JAFRA TIME DYNAMICS- octinoxate, zinc oxide cream

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

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Active ingredient:
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
Available from:
Jafra Cosmetics International
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Uses - 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 Stop use and ask a doctor if rash occurs
Authorization status:
OTC monograph final
Authorization number:
68828-201-01, 68828-201-02

DEFY TIME PROTECTOR MOISTURIZER BROAD SPECTRUM SPF 15 JAFRA TIME

DYNAMICS- octinoxate, zinc oxide cream

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.

----------

Active Ingredients Purpose

Octinoxate 7.5% Sunscreen

Zinc Oxide 3% 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 product is swallowed, get medical help or contact a Poison Contol

Center right away.

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 of SPF 15 or

higher and other sun protection measures including:

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

wear long-sleeve shirts, pants, hats, and sunglasses

Inactive Ingredients

Water/Aqua, Tridecyl Neopentanoate, Polyglyceryl-3 Methylglucose Distearate, Glyceryl Stearate,

Dimethicone, Glycerin, Triticum Vulgare (Wheat) Germ Protein, Avena Sativa (Oat) Kernel

Protein,Saccharide lsomerate, Polyacrylamide, C13-141soparaffin, Laureth-7, Panthenol, DMDM

Hydantoin, Diazolidinyl Urea, Biosaccharide Gum-4, Lecithin,Tocopheryl Acetate, Caprylic/Capric

Triglylceride, Ubiquinone, Diisopropyl Adipate, Alcohol, Chondrus Crispus (Carrageenan) Extract,

Chlorella Vulgaris Extract, Phytosterol lsostearate, Allantoin, Retinyl Palmitate, Ascorbyl

Methylsilanol Pectinate, Trisodium EDTA, PEG-4 Laurate, lodopropynyl Bulylcarbamate, Propylene

Glycol, Camellia Sinensis Leal Extract, Glycine Soja (Soybean) Seed Extract, Ceramide 3, Smithsonite

Extract

Jafra

time dynamics defy

Time protector Moisturizer broad spectrum SPF 15

50ml 1.7fl oz

DEFY TIME PROTECTOR MOISTURIZER BROAD SPECTRUM SPF 15 JAFRA

TIME DYNAMICS

octinoxate, zinc oxide cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 8 28 -20 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

OCTINOXATE

7.5 g in 10 0 mL

ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

ZINC OXIDE

3 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

TRIDECYL NEO PENTANO ATE (UNII: 3Z8 H1DA7J5)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

GLYCERIN (UNII: PDC6 A3C0 OX)

WHEAT GERM (UNII: YR3G36 9 F5A)

SACCHARIDE ISO MERATE (UNII: W8 K377W9 8 I)

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

C13 -14 ISO PARAFFIN (UNII: E4F12ROE70 )

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

PANTHENO L (UNII: WV9 CM0 O6 7Z)

DMDM HYDANTO IN (UNII: BYR0 546 TOW)

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

BIO SACCHARIDE GUM-4 (UNII: 9 XRL0 57X9 0 )

LECITHIN, SO YBEAN (UNII: 1DI56 QDM6 2)

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

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

UBIDECARENO NE (UNII: EJ27X76 M46 )

DIISO PRO PYL ADIPATE (UNII: P7E6 YFV72X)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

CHO NDRUS CRISPUS CARRAGEENAN (UNII: UE8 56 F2T78 )

CHLO RELLA VULGARIS (UNII: RYQ4R6 0 M0 2)

ALLANTO IN (UNII: 344S277G0 Z)

VITAMIN A PALMITATE (UNII: 1D1K0 N0 VVC)

ASCO RBYL METHYLSILANO L PECTINATE (UNII: M3PF9 237YC)

EDETATE TRISO DIUM (UNII: 420 IP9 21MB)

PEG-4 LAURATE (UNII: AYF4VM3N1Z)

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

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

GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )

SO YBEAN (UNII: L7HT8 F1ZOD)

CERAMIDE 3 (UNII: 4370 DF0 50 B)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 8 28 -20 1-0 2

1 in 1 CARTON

11/25/20 14

1

NDC:6 8 8 28 -20 1-0 1

50 mL in 1 JAR; 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

11/25/20 14

Labeler -

Jafra Cosmetics International (041676479)

Registrant -

Jafra Cosmetics International (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

ma nufa c ture (6 8 8 28 -20 1)

Jafra Cosmetics International

Revised: 5/2019

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