SUNSCREEN SPF 28- octinoxate zinc oxide cream

SUNSCREEN by

Drug Labeling and Warnings

SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by COSMOCEUTICAL RESEARCH CENTER INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

OCTINOXATE 7.5%
ZINC OXIDE 6%

PURPOSE

SUNSCREEN

INDICATION

HELPS PREVENT SUNBURN

WARNING

FOR EXTERNAL USE ONLY.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

DIRECTIONS

APPLY A THIN LAYER TO ALL EXPOSED AREAS. REAPPLY AFTER PROLONGED SWIMMING, EXTREME PERSPIRATION OR TOWEL DRYING.

INACTIVE INGREDIENTS

PURIFIED WATER, POLYGLYCERYL-4 ISOSTEARATE, CETYL DIMETHICONE COPOLYOL, HEXYL LAURATE, OCTYL PALMITATE, CYCLOMETHICONE, PHENYL TRIMETHICONE, CETYL DIMETHICONE, PHENOXYETHANOL, METHYLPARABEN, PROPYLPARABEN, ETHYLPARABEN, BUTYLPARABEN, SODIUM CHLORIDE, PROPYLENE GLYCOL, SODIUM PCA, ALOE BARBADENSIS EXTRACT, ALLANTOIN, TETRASODIUM EDTA, TOCOPHERYL ACETATE.

WHEN USING

WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNSCREEN  SPF 28
octinoxate zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66538-101
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 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CYCLOMETHICONE (UNII: NMQ347994Z)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ETHYLPARABEN (UNII: 14255EXE39)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ALLANTOIN (UNII: 344S277G0Z)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
ALOE (UNII: V5VD430YW9)
EDETATE SODIUM (UNII: MP1J8420LU)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66538-101-12	50 g in 1 JAR; Type 0: Not a Combination Product	11/28/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/28/2011

Labeler - COSMOCEUTICAL RESEARCH CENTER INC (160019006)

Registrant - COSMOCEUTICAL RESEARCH CENTER INC (160019006)