Label: BABY SKIN MINERAL SUNSCREEN- mineral sunscreen lotion
- NDC Code(s): 79265-8578-3
- Packager: Babo Botanicals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 12, 2024
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- Active Ingredient(s)
- Purpose
- Use
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- Other information
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Inactive ingredients
ARACHIDYL ALCOHOL, ARACHIDYL GLUCOSIDE, BEHENYL ALCOHOL, BISABOLOL*, BUTYLOCTYL SALICYLATE, BUTYROSPERMUM PARKII (SHEA BUTTER), CALENDULA OFFICINALIS FLOWER EXTRACT*, CAPRYLHYDROXAMIC ACID, CAPRYLYL GLYCOL, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, CELLULOSE GUM, CETEARYL ALCOHOL, CETYL ALCOHOL, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT*, CITRIC ACID, COCO-GLUCOSIDE, COCOS NUCIFERA (COCONUT) OIL, GLYCERIN, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, METHYL DIHYDROABIETATE, MICROCRYSTAL-LINE CELLULOSE, NASTURTIUM OFFICINALE FLOWER/LEAF EXTRACT*, POLYHYDROXYSTEARIC ACID, PUERARIA LOBATA ROOT EXTRACT*, SODIUM GLUCONATE, SODIUM HYALURONATE, SODIUM STEAROYL GLUTAMATE, SPIRAEA ULMARIA FLOWER EXTRACT*, THEOBROMA CACAO (COCOA) SEED BUTTER*, TOCOPHEROL, WATER (AQUA).*Certified Organic Ingredients
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INGREDIENTS AND APPEARANCE
BABY SKIN MINERAL SUNSCREEN
mineral sunscreen lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79265-8578 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 20 g in 100 mL Inactive Ingredients Ingredient Name Strength CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) 0.0001 mL in 100 mL PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C) 0.0001 mL in 100 mL CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 1.3 mL in 100 mL HYALURONATE SODIUM (UNII: YSE9PPT4TH) 0.2 mL in 100 mL SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) 1.3 mL in 100 mL TOCOPHEROL (UNII: R0ZB2556P8) 0.75 mL in 100 mL LEVOMENOL (UNII: 24WE03BX2T) 0.3 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 0.15 mL in 100 mL WATER (UNII: 059QF0KO0R) 46.0495 mL in 100 mL NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G) 0.0001 mL in 100 mL POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) 0.25 mL in 100 mL SODIUM GLUCONATE (UNII: R6Q3791S76) 0.2 mL in 100 mL CETYL ALCOHOL (UNII: 936JST6JCN) 0.75 mL in 100 mL CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.2 mL in 100 mL CAPRYLYL GLYCOL (UNII: 00YIU5438U) 0.7 mL in 100 mL CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) 0.144 mL in 100 mL CHAMOMILE (UNII: FGL3685T2X) 0.0001 mL in 100 mL BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) 5 mL in 100 mL ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) 0.972 mL in 100 mL ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) 0.324 mL in 100 mL DOCOSANOL (UNII: 9G1OE216XY) 0.504 mL in 100 mL SHEA BUTTER (UNII: K49155WL9Y) 2.1 mL in 100 mL CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) 0.15 mL in 100 mL METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) 3 mL in 100 mL COCO GLUCOSIDE (UNII: ICS790225B) 0.7 mL in 100 mL COCONUT OIL (UNII: Q9L0O73W7L) 5 mL in 100 mL SUNFLOWER OIL (UNII: 3W1JG795YI) 5.1 mL in 100 mL MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) 1.056 mL in 100 mL FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6) 0.0001 mL in 100 mL COCOA BUTTER (UNII: 512OYT1CRR) 0.8 mL in 100 mL SAFFLOWER OIL (UNII: 65UEH262IS) 3 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79265-8578-3 89 mL in 1 TUBE; Type 0: Not a Combination Product 08/26/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 08/26/2020 02/28/2026 Labeler - Babo Botanicals, Inc. (058258734) Registrant - Bell International Laboratories (967781555) Establishment Name Address ID/FEI Business Operations Bell International Laboratories 967781555 manufacture(79265-8578)
