Label: ALBA BOTANICA BABY MINERAL SUNSCREEN SPF45- zinc oxide, titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 61995-2017-1 - 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 April 12, 2021
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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, Caprylic Capric Triglyceride, Isoamyl Laurate, Coconut Alkanes,Polyglyceryl-2 Sesquioleate, Glycerin, Polyglyceryl-3 Ricinoleate, Aloe Barbadensis Leaf Juice(1), Crambe Abyssinica Seed Oil, Polyhydroxystearic Acid, Alumina, Stearic Acid, Butyrospermum Parkii (Shea) Butter, Camilla Sinensis Leaf Extract (1), Echinacea Purpurea Extract, Ginkgo Biloba Leaf Extract (1), Polygonum Aviculare Extract, Tocopheryl Acetate, Citric Acid, Coco-Caprylate/Caprate, Magnesium Sulfate, Sodium Chloride, Sorbitan Sesquioleate, Alcohol (1), Benzyl Alcohol, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate.
(1) Certified Organicf Ingredient
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INDICATIONS & USAGE
Helps prevents sunburns. If uses 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 BABY MINERAL SUNSCREEN SPF45
zinc oxide, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-2017 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 7 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 9 g in 100 g Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) POLYGLYCERYL-2 SESQUIOLEATE (UNII: RHP7Q83BVB) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) CAPRYLIC/CAPRIC ACID (UNII: DI775RT244) ALCOHOL (UNII: 3K9958V90M) BENZYL ALCOHOL (UNII: LKG8494WBH) PHENOXYETHANOL (UNII: HIE492ZZ3T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) ALOE VERA LEAF (UNII: ZY81Z83H0X) ISOAMYL LAURATE (UNII: M1SLX00M3M) COCONUT ALKANES (UNII: 1E5KJY107T) GLYCERIN (UNII: PDC6A3C0OX) POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K) WATER (UNII: 059QF0KO0R) POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF) SHEA BUTTER (UNII: K49155WL9Y) GREEN TEA LEAF (UNII: W2ZU1RY8B0) GINKGO (UNII: 19FUJ2C58T) ALUMINUM OXIDE (UNII: LMI26O6933) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) SODIUM CHLORIDE (UNII: 451W47IQ8X) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) STEARIC ACID (UNII: 4ELV7Z65AP) ECHINACEA PURPUREA ROOT (UNII: OS64WTR4KU) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61995-2017-1 85 g in 1 TUBE; Type 0: Not a Combination Product 12/19/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/19/2019 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(61995-2017)
