Label: SUNBETTER BROAD SPECTRUM SPF 70 SUNSCREEN SHEER- zinc oxide, titanium dioxide lotion
- NDC Code(s): 62282-377-01, 62282-377-02, 62282-377-03
- Packager: Northwest Cosmetic Laboratories, LLC D.B.A Elevation Labs Idaho
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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Drug Label Information
Updated November 3, 2022
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INGREDIENTS AND APPEARANCE
SUNBETTER BROAD SPECTRUM SPF 70 SUNSCREEN SHEER
zinc oxide, titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62282-377 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 100 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 36 mg in 1 mL Inactive Ingredients Ingredient Name Strength MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M) NIACINAMIDE (UNII: 25X51I8RD4) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) POLYGLYCERYL-4 OLEATE (UNII: 15B05TY4GX) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) ALUMINUM OXIDE (UNII: LMI26O6933) HIMANTHALIA ELONGATA (UNII: 21RND18XRR) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) CERIC OXIDE (UNII: 619G5K328Y) STEARIC ACID (UNII: 4ELV7Z65AP) WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) CETYL DIMETHICONE 45 (UNII: IK315POC44) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CAPRYLYL GLYCOL (UNII: 00YIU5438U) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) DODECAMETHYLPENTASILOXANE (UNII: 0QDQ2VQ5YJ) STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SQUALANE (UNII: GW89575KF9) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC) PANTHENOL (UNII: WV9CM0O67Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62282-377-01 1 in 1 CARTON 02/02/2021 1 50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:62282-377-02 15 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 02/01/2021 3 NDC:62282-377-03 1 mL in 1 PACKET; Type 0: Not a Combination Product 02/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/01/2021 Labeler - Northwest Cosmetic Laboratories, LLC D.B.A Elevation Labs Idaho (929572014)