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

defy time protector moisturizer broad spectrum SPF 15 by

Drug Labeling and Warnings

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                     Purpose

Octinoxate  7.5%                         Sunscreen

Zinc Oxide  3%                            Sunscreen

PURPOSE

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

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

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

WARNINGS

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.

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

Jafra

time dynamics defy

Time protector Moisturizer broad spectrum SPF 15

50ml 1.7fl oz

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-201
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
WATER (UNII: 059QF0KO0R)
TRIDECYL NEOPENTANOATE (UNII: 3Z8H1DA7J5)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
WHEAT GERM (UNII: YR3G369F5A)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
PANTHENOL (UNII: WV9CM0O67Z)
DMDM HYDANTOIN (UNII: BYR0546TOW)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
UBIDECARENONE (UNII: EJ27X76M46)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
ALCOHOL (UNII: 3K9958V90M)
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
ALLANTOIN (UNII: 344S277G0Z)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ASCORBYL METHYLSILANOL PECTINATE (UNII: M3PF9237YC)
EDETATE TRISODIUM (UNII: 420IP921MB)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SOYBEAN (UNII: L7HT8F1ZOD)
CERAMIDE 3 (UNII: 4370DF050B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-201-02	1 in 1 CARTON	11/25/2014
1	NDC: 68828-201-01	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	11/25/2014

Labeler - Jafra Cosmetics International (041676479)

Registrant - Jafra Cosmetics International (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Jafra Manufacturing S.A. de C.V.		814732061	manufacture(68828-201)