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

Time Dynamics by

Drug Labeling and Warnings

Time Dynamics by is a Otc medication manufactured, distributed, or labeled by Jafra Cosmetics International Inc, Jafra Manufacturing, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - Jafra Cosmetics International Inc (041676479)

Registrant - Jafra Cosmetics International Inc (041676479)

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