REPLENISHING SUNSCREEN SPF 36- sunscreen cream

Replenishing Sunscreen SPF 36 by

Drug Labeling and Warnings

Replenishing Sunscreen SPF 36 by is a Otc medication manufactured, distributed, or labeled by CosMedical Technologies, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

PURPOSE

INACTIVE INGREDIENT

WARNINGS AND PRECAUTIONS

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REPLENISHING SUNSCREEN SPF 36 
sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70060-1501
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g  in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	5 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)
CASTOR OIL (UNII: D5340Y2I9G)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70060-1501-1	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/18/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/18/2015

Labeler - CosMedical Technologies, LLC (803898329)

Registrant - CosMedical Technologies, LLC (803898329)