DAILY DEFENSE SPF 15 JAFRA- octinoxate, 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-131
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-131-021 in 1 CARTON05/30/2012
1NDC:68828-131-0150 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/30/2012
Labeler - Jafra Cosmetics International Inc (041676479)
Registrant - Jafra Cosmetics International Inc (041676479)
Establishment
NameAddressID/FEIBusiness Operations
Jafra Manufacturing, S.A. de C.V.814732061manufacture(68828-131)

Revised: 12/2018
Document Id: d9abf19c-07f0-473b-b028-63fc66c832ed
Set id: 82f91405-b392-4bf1-90da-1f09ae072b86
Version: 2
Effective Time: 20181206
 
Jafra Cosmetics International Inc