Label: KISS THERAPY SPF 30 STRAWBERRY MINT LIP BALM- avobenzone, homosalate, octocrylene stick
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Contains inactivated NDC Code(s)
NDC Code(s): 12027-211-01, 12027-211-02 - Packager: Marwins Beauty Products, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 15, 2018
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INGREDIENTS AND APPEARANCE
KISS THERAPY SPF 30 STRAWBERRY MINT LIP BALM
avobenzone, homosalate, octocrylene stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:12027-211 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/02/2018 Labeler - Marwins Beauty Products, Inc. (135407760)