TIME DYNAMICS DEFY TIME PROTECTOR MOISTURIZER BROAD SPECTRUM SPF 15- 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.

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Active Ingredients 

Octinoxate  7.5%

Zinc Oxide  3%

Purpose

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.

Warnings

For external use only

Do not useon damaged or broken skin

When using this productkeep out of eyes. Rinse with water to remove.

Stop use and ask a doctorif rash occurs

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

Directions

Inactive Ingredients

Alcohol, Allantoin, Ascorbyl Methylsilanol Pectinate, Avena Sativa (Oat) Kernel Extract, Biosaccharide Gum-4, C13-14 Isoparaffin, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglylceride, Ceramide 3, Chlorella Vulgaris Extract, Chondrus Crispus (Carrageenan) Extract, Diazolidinyl Urea, Diisopropyl Adipate, DMDM Hydantoin, Glycerin, Triticum Vulgare (Wheat) Germ Protein, Glyceryl Stearate, Glycine Soja (Soybean) Seed Extract, Iodopropynyl Bulylcarbamate, Laureth-7, Lecithin, Panthenol, PEG-4 Laurate, Phytosterol Isostearate, Polyacrylamide, Polyglyceryl-3 Methylglucose Distearate, Propylene Glycol, Retinyl Palmitate, Saccharide Isomerate, Smithsonite Extract, Tocopheryl Acetate, Tridecyl Neopentanoate, Triethoxycaprylylsilane, Trisodium EDTA, Ubiquinone, Water/Aqua

Other information

Protect this product from excessive heat and direct sun

Product label

image description

TIME DYNAMICS DEFY TIME PROTECTOR MOISTURIZER BROAD SPECTRUM SPF 15 
octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-750
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
ALCOHOL (UNII: 3K9958V90M)  
ALLANTOIN (UNII: 344S277G0Z)  
ASCORBYL METHYLSILANOL PECTINATE (UNII: M3PF9237YC)  
OAT (UNII: Z6J799EAJK)  
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CERAMIDE NP (UNII: 4370DF050B)  
CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
GLYCERIN (UNII: PDC6A3C0OX)  
WHEAT GERM (UNII: YR3G369F5A)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
SOYBEAN (UNII: L7HT8F1ZOD)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
LAURETH-7 (UNII: Z95S6G8201)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
PANTHENOL (UNII: WV9CM0O67Z)  
PEG-4 LAURATE (UNII: AYF4VM3N1Z)  
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (UNII: W19EIO0DBE)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TRIDECYL NEOPENTANOATE (UNII: 3Z8H1DA7J5)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
UBIDECARENONE (UNII: EJ27X76M46)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-750-021 in 1 CARTON01/11/202203/01/2022
1NDC:68828-750-0150 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/11/2022
Labeler - Jafra Cosmetics International (041676479)
Registrant - Jafra Cosmetics International (041676479)
Establishment
NameAddressID/FEIBusiness Operations
Distribuidora Comercial Jafra, S.A. de C.V.951612777manufacture(68828-750)

Revised: 7/2023
Document Id: 014f1032-f856-a0ab-e063-6294a90a7585
Set id: 3b84c856-62f2-4323-9229-7c184e3ceafc
Version: 4
Effective Time: 20230725
 
Jafra Cosmetics International