KISS THERAPY SPF 30 STRAWBERRY MINT LIP BALM- avobenzone, homosalate, octocrylene stick
Marwins Beauty Products, Inc.

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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KISS THERAPY SPF 30 STRAWBERRY MINT LIP BALM
avobenzone, homosalate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:12027-211
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
YELLOW WAX (UNII: 2ZA36H0S2V)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MANDARIN OIL (UNII: NJO720F72R)
COCONUT OIL (UNII: Q9L0O73W7L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
RASPBERRY SEED OIL (UNII: 9S8867952A)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ACAI OIL (UNII: Z0W6766A2W)
KONJAC MANNAN (UNII: 36W3E5TAMG)
JOJOBA OIL (UNII: 724GKU717M)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
SYNTHETIC WAX (2900 MW) (UNII: U5UP035C8A)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:12027-211-02	1 in 1 BLISTER PACK	01/02/2018
1	NDC:12027-211-01	3.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	01/02/2018

Labeler - Marwins Beauty Products, Inc. (135407760)