SPF 15 LIP BALM KEY LIME- spf 15 lip balm key lime 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 Natural Lip Balm with Zinc Oxide, SPF 15 - Key Lime

OTC - ACTIVE INGREDIENT

OTC Active Ingredients

OTC - PURPOSE

OTC Purpose

ARTWORK

Artwork

SPF 15 LIP BALM KEY LIME
spf 15 lip balm key lime stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62932-244
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
SUNFLOWER OIL (UNII: 3W1JG795YI)
SHEA BUTTER (UNII: K49155WL9Y)
.DELTA.-TOCOPHEROL (UNII: JU84X1II0N)
COCONUT OIL (UNII: Q9L0O73W7L)
WHITE WAX (UNII: 7G1J5DA97F)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
RASPBERRY SEED OIL (UNII: 9S8867952A)
COCOA BUTTER (UNII: 512OYT1CRR)
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)
.BETA.-TOCOPHEROL (UNII: 9U6A490501)
JOJOBA OIL (UNII: 724GKU717M)
TAMANU OIL (UNII: JT3LVK84A1)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
.GAMMA.-TOCOPHEROL (UNII: 8EF1Z1238F)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	LIME (KEY LIME)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62932-244-38	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)

Registrant - Private Label Select Ltd CO (005415463)