Label: ALBA MINERAL SUNSCREEN SPORT SPF45 BROAD SPECTRUM- zinc oxide, titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 61995-2400-4 - 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 October 14, 2014
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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, Crambe Abyssinica Seed Oil, Aloe Barbadensis Leaf Juice(1), Polyhydroxystearic Acid, Echinacea Purpurea Extract, Polygonum Aviculare Extract, Tocopheryl Acetate, Butyrospermum Parkii (Shea) Butter, Camilla Sinensis Leaf Extract (1), Ginkgo Biloba Leaf Extract (1), Brassica Campestris (Rapeseed) Seed Oil, Alumina, Coco-Caprylate/Caprate, Magnesium Sulfate, Sodium Chloride, Sorbitan Sesquioleate, Stearic Acid, Alcohol (1), Benzyl Alcohol, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate.
(1) Certified Organicf Ingredient
- PRINCIPAL DISPLAY PANEL
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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.
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INGREDIENTS AND APPEARANCE
ALBA MINERAL SUNSCREEN SPORT SPF45 BROAD SPECTRUM
zinc oxide, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-2400 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 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) BRASSICA RAPA SUBSP. OLEIFERA OIL (UNII: N4G8379626) ALUMINUM OXIDE (UNII: LMI26O6933) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) MAGNESIUM SULFATE (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) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61995-2400-4 113 g in 1 TUBE; Type 0: Not a Combination Product 12/27/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/27/2013 Labeler - The Hain Celestial Group, Inc. (858894996) Registrant - The Hain Celestial Group, Inc. (858894996) Establishment Name Address ID/FEI Business Operations The Hain Celestial Group, Inc. 858894996 manufacture(61995-2400)
