TINTED MINERAL SUNSCREEN, SPF 30 MEDIUM TINT- 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.

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Olita Inc., Tinted Mineral Sunscreen, SPF 30 (Medium Tint)

OTC - Active Section

OTC Active Ingredients

OTC - Purpose

OTC Purpose

Dosage & Administration

Dosage and Administration

Inactive Ingredients

Indications and Usage

Warnings

Warnings Section

Artwork

TINTED MINERAL SUNSCREEN, SPF 30 MEDIUM TINT
sunscreen ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62932-262
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
.DELTA.-TOCOPHEROL (UNII: JU84X1II0N)
WHITE WAX (UNII: 7G1J5DA97F)
OLIVE OIL (UNII: 6UYK2W1W1E)
FERRIC OXYHYDROXIDE (UNII: 87PZU03K0K)
JOJOBA OIL (UNII: 724GKU717M)
SHEA BUTTER (UNII: K49155WL9Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.GAMMA.-TOCOPHEROL (UNII: 8EF1Z1238F)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
.BETA.-TOCOPHEROL (UNII: 9U6A490501)
SUNFLOWER OIL (UNII: 3W1JG795YI)
MICA (UNII: V8A1AW0880)
CASTOR OIL (UNII: D5340Y2I9G)
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)

Product Characteristics
Color	brown (Medium Tint)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62932-262-46	89 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	01/01/2021

Labeler - Private Label Select Ltd CO (005415463)