DAILY DEFENSE SPF 15 JAFRA- octinoxate and zinc oxide cream 
Jafra Cosmetics International 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.

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Time Protector Daily Defense Cream Broad Spectrum SPF 15

Active ingredients purpose

Octinoxate 7.5% Sunscreen

Zinc Oxide 3% Sunscreen

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.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control 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 lliberally 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. - 2p.m.

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

Water/Aqua, Gelatin, Retinyl Palmitate, Tridecyl Neopentanoate, Polyglyceryl-3 Methylglucose Distearate, Dimethicone, Glyceryl Stearate, Glycerin, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Triticum vulgare (Wheat) Germ Protein, Avena Sativa (Oat) Kernel Protein, Saccharide Isomerate, Glycine Soja (Soybean) Seed Extract, Ceramide 3, Propylene Glycol, Camellia Sinensis Leaf Extract, Panthenol, Ubiquinone, Chondrus Crispus (Carrageenan) Extract, Biosaccharide Gum-4, Chlorella Vulgaris extract, Phytosterol Isostearate, Allantoin, Ascorbyl Methylsilanol Pectinate, Tocopheryl Acetate, Lecithin, Caprylic/Capric Triglyceride, Diisopropyl Adipate, Trisodium EDTA, Diazolidnyl Urea, Methylparaben, Propylparaben.

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Jafra Time Dynamics

Time Dynamics

Time Protector Daily Defense Cream

Broad Spectrum SPF 15 with intellishield

cont. Net. 50 ml 1.7 Fl Oz (US)

DAILY DEFENSE SPF 15  JAFRA
octinoxate, zinc oxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-131
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 3 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
TRIDECYL NEOPENTANOATE (UNII: 3Z8H1DA7J5)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
LAURETH-7 (UNII: Z95S6G8201)  
WHEAT GERM (UNII: YR3G369F5A)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
CERAMIDE 3 (UNII: 4370DF050B)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
PANTHENOL (UNII: WV9CM0O67Z)  
CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
ALLANTOIN (UNII: 344S277G0Z)  
ASCORBYL METHYLSILANOL PECTINATE (UNII: M3PF9237YC)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68828-131-02 1 in 1 CARTON
1 NDC:68828-131-01 50 mL in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 05/30/2012
Labeler - Jafra Cosmetics International Inc (041676479)
Registrant - Jafra Cosmetics International Inc (041676479)
Establishment
Name Address ID/FEI Business Operations
Jafra Manufacturing, S.A. de C.V. 814732061 manufacture(68828-131)

Revised: 3/2013
Document Id: a2971002-0c1b-45ed-9606-5c11e1854426
Set id: 82f91405-b392-4bf1-90da-1f09ae072b86
Version: 1
Effective Time: 20130326
 
Jafra Cosmetics International Inc