ZINC OXIDE LIP BALM PINA COLADA- zinc oxide lip balm pina colada 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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Summer Lotion SPF 15 Lip Balm Pina Colada

OTC ACTIVE INGREDIENT

OTC Active Ingredients

OTC PURPOSE SECTION

OTC Purpose

ARTWORK

Artwork

ZINC OXIDE LIP BALM PINA COLADA
zinc oxide lip balm pina colada stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62932-245
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	10 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
.BETA.-TOCOPHEROL (UNII: 9U6A490501)
.GAMMA.-TOCOPHEROL (UNII: 8EF1Z1238F)
JOJOBA OIL (UNII: 724GKU717M)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
COCOA BUTTER (UNII: 512OYT1CRR)
COCONUT OIL (UNII: Q9L0O73W7L)
SHEA BUTTER (UNII: K49155WL9Y)
RASPBERRY SEED OIL (UNII: 9S8867952A)
SUNFLOWER OIL (UNII: 3W1JG795YI)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)
.DELTA.-TOCOPHEROL (UNII: JU84X1II0N)
TAMANU OIL (UNII: JT3LVK84A1)
WHITE WAX (UNII: 7G1J5DA97F)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	PINEAPPLE (Pina-colada)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62932-245-38	4.2 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)