SUNSCREEN- 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.

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Rinse Bath & Body SPF 30 Unscented Sunstick

OTC - ACTIVE INGREDIENT SECTION

OTC Active Ingredients

OTC - KEEP OUT OF REACH OF CHILDREN

OTC Keep Out Of Reach Of Children

OTC - PURPOSE

OTC Purpose

ARTWORK (BACK LABEL NO. 1)

ARTWORK - BACK

ARTWORK (BACK LABEL NO. 2)

ARTWORK - BACK

ARTWORK (FRONT LABEL)

Artwork

ARTWORK (BACK LABEL NO. 3)

ARTWORK - BACK

SUNSCREEN
zinc oxide sunscreen stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62932-243
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
SUNFLOWER OIL (UNII: 3W1JG795YI)
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.GAMMA.-TOCOPHEROL (UNII: 8EF1Z1238F)
.DELTA.-TOCOPHEROL (UNII: JU84X1II0N)
SHEA BUTTER (UNII: K49155WL9Y)
WHITE WAX (UNII: 7G1J5DA97F)
CANDELILLA WAX (UNII: WL0328HX19)
COCOA BUTTER (UNII: 512OYT1CRR)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CASTOR OIL (UNII: D5340Y2I9G)
.BETA.-TOCOPHEROL (UNII: 9U6A490501)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62932-243-42	18 g in 1 CONTAINER; Type 0: Not a Combination Product	01/01/2020

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

Labeler - Private Label Select Ltd CO (005415463)