Label: AL0043700 ALBA BOTANICA BABY MINERAL SUNSCREEN SPF50- zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 61995-2437-4 - 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 February 5, 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, Coconut Alkanes, Mica, Glycerin, Polyglyceryl-2 Sesquioleate, Polyglyceryl-3 Ricinoleate, Glyceryl Isostearate, Aloe Barbadensis Leaf Juice(1), Butyrospermum Parkii (Shea) Butter,Citrus Aurantium Dulcis (Orange) Peel Oil, Copernica Cerifera (Carnauba) Wax, Juniperus Virginiana Oil, Camilla Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Brassica Alcohol, Coco-Caprylate/Caprate, Sodium Chloride, Alcohol (1), Polyhydroxystearic Acid,Tocopheryl Acetate, Biosaccharide Gum-1,C10-18 Triglycerides, Cetearyl Olivate, Glyceryl Caprylate, Potassium Hydroxide, Quartz, Sodium Anisate, Sorbitan Olivate, Ethylhexylglycerin.
(1) Certified Organicf Ingredient
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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
AL0043700 ALBA BOTANICA BABY MINERAL SUNSCREEN SPF50
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-2437 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 17 g in 100 g Inactive Ingredients Ingredient Name Strength MICA (UNII: V8A1AW0880) BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H) ORANGE OIL (UNII: AKN3KSD11B) POLYGLYCERYL-2 SESQUIISOSTEARATE (UNII: LA272Q68GQ) CARNAUBA WAX (UNII: R12CBM0EIZ) ALCOHOL (UNII: 3K9958V90M) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALOE VERA LEAF (UNII: ZY81Z83H0X) COCONUT ALKANES (UNII: 1E5KJY107T) GLYCERIN (UNII: PDC6A3C0OX) POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) WATER (UNII: 059QF0KO0R) SHEA BUTTER (UNII: K49155WL9Y) GREEN TEA LEAF (UNII: W2ZU1RY8B0) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) SODIUM CHLORIDE (UNII: 451W47IQ8X) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) CETEARYL OLIVATE (UNII: 58B69Q84JO) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CHAMOMILE (UNII: FGL3685T2X) JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61995-2437-4 113 g in 1 TUBE; Type 0: Not a Combination Product 12/21/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/21/2017 Labeler - The Hain Celestial Group, Inc. (117115556) Registrant - The Hain Celestial Group, Inc. (014334364) Establishment Name Address ID/FEI Business Operations The Hain Celestial Group, Inc. 081512382 manufacture(61995-2437)
