TINTED SUNSCREEN- tinted zinc oxide sunscreen stick
Private Label Select Ltd CO

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.

----------

Protekt Tinted SPF 30 Mineral Sunscreen

OTC Active Ingredient Section

OTC Active Ingredients

OTC Keep out of reach of children

OTC Keep Out Of Reach Of Children

OTC Purpose

ARTWORK (FRONT)

Artwork

ARTWORK (BACK)

Artwork

TINTED SUNSCREEN
tinted zinc oxide sunscreen stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62932-240
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WHITE WAX (UNII: 7G1J5DA97F)
CANDELILLA WAX (UNII: WL0328HX19)
FERRIC OXYHYDROXIDE (UNII: 87PZU03K0K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SUNFLOWER OIL (UNII: 3W1JG795YI)
.DELTA.-TOCOPHEROL (UNII: JU84X1II0N)
COCOA BUTTER (UNII: 512OYT1CRR)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.GAMMA.-TOCOPHEROL (UNII: 8EF1Z1238F)
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)
.BETA.-TOCOPHEROL (UNII: 9U6A490501)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SHEA BUTTER (UNII: K49155WL9Y)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CASTOR OIL (UNII: D5340Y2I9G)
MICA (UNII: V8A1AW0880)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62932-240-34	14 g in 1 CONTAINER; Type 0: Not a Combination Product	02/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	02/01/2020

Labeler - Private Label Select Ltd CO (005415463)