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

Time Dynamics Defy Time Protector Moisturizer Broad Spectrum SPF 15 by

Drug Labeling and Warnings

Time Dynamics Defy Time Protector Moisturizer Broad Spectrum SPF 15 by is a Otc medication manufactured, distributed, or labeled by Jafra Cosmetics International, Jafra Manufacturing S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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.

KEEP OUT OF REACH OF CHILDREN

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 value 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

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-750
Route of Administration	TOPICAL

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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-750-02	1 in 1 CARTON	01/11/2022	03/01/2022
1	NDC: 68828-750-01	50 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/11/2022

Labeler - Jafra Cosmetics International (041676479)

Registrant - Jafra Cosmetics International (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Distribuidora Comercial Jafra, S.A. de C.V.		951612777	manufacture(68828-750)