SKIN PROTECTANT- skin protectant lotion
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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Earth Mama Tinted Mineral Sunscreen Lotion Broad Spectrum SPF 40

OTC ACTIVE INGREDIENT

OTC Active Ingredients

OTC PURPOSE SECTION

OTC Purpose

OTC KEEP OUT OF REACH OF CHILDREN

OTC Keep Out Of Reach Of Children

ARTWORK

Artwork

SKIN PROTECTANT
skin protectant lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62932-227
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	25 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)
.BETA.-TOCOPHEROL (UNII: 9U6A490501)
.DELTA.-TOCOPHEROL (UNII: JU84X1II0N)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
OLIVE OIL (UNII: 6UYK2W1W1E)
FERRIC OXYHYDROXIDE (UNII: 87PZU03K0K)
.GAMMA.-TOCOPHEROL (UNII: 8EF1Z1238F)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ARGAN OIL (UNII: 4V59G5UW9X)
MICA (UNII: V8A1AW0880)
SHEA BUTTER (UNII: K49155WL9Y)
JOJOBA OIL (UNII: 724GKU717M)
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)
COCONUT OIL (UNII: Q9L0O73W7L)
WHITE WAX (UNII: 7G1J5DA97F)
RASPBERRY SEED OIL (UNII: 9S8867952A)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62932-227-40	84 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)