SUNSCREEN- zinc oxide sunscreen ointment
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.

----------

Suntegrity Natural Mineral Tinted Sunscreen Sport, Natural Tint

OTC Purpose Section

OTC Purpose

OTC Active Ingredient Section

OTC Active Ingredients

OTC- Keep Out of Reach of Children

OTC Keep Out Of Reach Of Children

ARTWORK (SQZ TUBE)

Artwork

SUNSCREEN
zinc oxide sunscreen ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62932-246
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
SHEA BUTTER (UNII: K49155WL9Y)
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)
MICA (UNII: V8A1AW0880)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
WHITE WAX (UNII: 7G1J5DA97F)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CASTOR OIL (UNII: D5340Y2I9G)
OLIVE OIL (UNII: 6UYK2W1W1E)
JOJOBA OIL (UNII: 724GKU717M)
FERRIC OXYHYDROXIDE (UNII: 87PZU03K0K)
.DELTA.-TOCOPHEROL (UNII: JU84X1II0N)
.GAMMA.-TOCOPHEROL (UNII: 8EF1Z1238F)
.BETA.-TOCOPHEROL (UNII: 9U6A490501)

Product Characteristics
Color	brown (Light Tan)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62932-246-41	85 g in 1 TUBE; 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)