Label: ALBA BOTANICA SHEER MINERAL SPF 50- zinc oxide, titanium dioxide aerosol
- NDC Code(s): 61995-3032-1, 61995-3032-2, 61995-3032-3
- Packager: The Hain Celestial Group, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 June 13, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
Water (Aqua), Helianthus Annuus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Butyloctyl Salicylate, Cocos Nucifera (Coconut) Oil, Capryloyl Glycerin/Sebacic Acid Copolymer, Heptyl Undecylenate, Methyl Dihydrobietate, Cetearyl Alcohol, Propanediol, Sodium Stearoyl Glutamate, Bentonite, Tocopherol, Caprylyl Glycol, Coco-Glucoside, Microcrystalline Cellulose, Bisabolol, Alumina, Polyhydroxystearic Acid, Citric Acid, Sodium Gluconate, Caprylhydroxamic Acid, Glycerin, Silica, Cellulose Gum, Aloe Barbadensis Leaf Juice
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INDICATIONS & USAGE
Helps prevents sunburns. If used as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALBA BOTANICA SHEER MINERAL SPF 50
zinc oxide, titanium dioxide aerosolProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-3032 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 14.7 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4.3 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) SODIUM GLUCONATE (UNII: R6Q3791S76) SUNFLOWER OIL (UNII: 3W1JG795YI) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PROPANEDIOL (UNII: 5965N8W85T) COCO GLUCOSIDE (UNII: ICS790225B) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) .BETA.-BISABOLOL (UNII: LP618AV2EA) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) OLIVE OIL (UNII: 6UYK2W1W1E) COCONUT OIL (UNII: Q9L0O73W7L) HEPTYL UNDECYLENATE (UNII: W77QUB6GXO) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) ALOE VERA LEAF (UNII: ZY81Z83H0X) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) BENTONITE (UNII: A3N5ZCN45C) ALUMINUM OXIDE (UNII: LMI26O6933) CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61995-3032-1 148 g in 1 CAN; Type 0: Not a Combination Product 01/01/2022 2 NDC:61995-3032-2 177 g in 1 CAN; Type 0: Not a Combination Product 01/01/2022 3 NDC:61995-3032-3 237 g in 1 CAN; Type 0: Not a Combination Product 01/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2022 Labeler - The Hain Celestial Group, Inc. (117115556) Registrant - The Hain Celestial Group, Inc. (081512382) Establishment Name Address ID/FEI Business Operations The Hain Celestial Group, Inc. 081512382 manufacture(61995-3032)
