Time Protector Daily Defense Cream SPF 15

TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15- octinoxate, zinc oxide cream, augmented
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.

----------

Sunscreen Active Ingredients (SPF 15): Octinoxate/Ethylhexyl Methoxycinnamate, Zinc Oxide

Purpose: Sunscreen

Keep out of reach of children

Discontinue use if signs of irritation occur.

Cautions: For external use only. Avoid contact with eyes.

To use: In the morning after cleansing. Smooth over face and throat. Clinically, allergy, irritancy tested.

Other ingredients: Water/Aqua, Gelatin, Retinyl Palmitate, Tridecyl Neopentanoate, Polyglyceryl-3 Methylglucose Distearate, Dimethicone, Glyceryl Stearate, Glycerin, Polacrylamide, 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, Diazolidinyl Urea, Methylparaben, Propylparaben.

Jafra
Time Dynamics

Time protector Daily Defense Cream SPF 15
Crema Facial Hidratante De Dia Con *FPS 15

with/con intellishield

50 ml 1.7 Fl Oz

TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15
octinoxate, zinc oxide cream, augmented

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68828-098
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.75 mL in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.5 mL in 50 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GELATIN (UNII: 2G86QN327L)
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)
SOYBEAN (UNII: L7HT8F1ZOD)
CERAMIDE 3 (UNII: 4370DF050B)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
PANTHENOL (UNII: WV9CM0O67Z)
UBIDECARENONE (UNII: EJ27X76M46)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL METHYLSILANOL PECTINATE (UNII: M3PF9237YC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
EDETATE TRISODIUM (UNII: 420IP921MB)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

#	Item Code	Package Description
Packaging
1	NDC:68828-098-01	1 in 1 CARTON
1		50 mL in 1 JAR

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	05/30/2012

Labeler - Jafra Cosmetics International Inc (041676479)

Registrant - Jafra Cosmetics International Inc (041676479)

Name	Address	ID/FEI	Business Operations
Establishment
Jafra Manufacturing, S.A. de C.V.		814732061	manufacture