DAILY DEFENSE SPF 15 JAFRA- octinoxate, zinc oxide cream

Daily Defense SPF 15 by

Drug Labeling and Warnings

Daily Defense SPF 15 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

Active ingredients purpose

Octinoxate 7.5% Sunscreen

Zinc Oxide 3% 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.

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

Stop use and ask a doctor if rash occurs

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.

Directions

apply lliberally 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 SPF value of 15 or higher and other sun protection measures including:

    limit time in the sun, especially from 10 a.m. - 2p.m.

    wear long sleeve shirts, pants, hats, and sunglasses.

Water/Aqua, Gelatin, Retinyl Palmitate, Tridecyl Neopentanoate, Polyglyceryl-3 Methylglucose Distearate, Dimethicone, Glyceryl Stearate, Glycerin, Polyacrylamide, 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, Diazolidnyl Urea, Methylparaben, Propylparaben.

PRINCIPAL DISPLAY PANEL

Jafra Time Dynamics

Time Dynamics

Time Protector Daily Defense Cream

Broad Spectrum SPF 15 with intellishield

cont. Net. 50 ml 1.7 Fl Oz (US)

INGREDIENTS AND APPEARANCE

DAILY DEFENSE SPF 15  JAFRA
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-131
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)
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)
CERAMIDE 3 (UNII: 4370DF050B)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
PANTHENOL (UNII: WV9CM0O67Z)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL METHYLSILANOL PECTINATE (UNII: M3PF9237YC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
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: 68828-131-02	1 in 1 CARTON	05/30/2012
1	NDC: 68828-131-01	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 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(68828-131)