Label: ALBA BOTANICA KIDS MINERAL SUNSCREEN FF SPF30- zinc oxide, titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 61995-2088-4 - 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 April 12, 2021
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- ACTIVE INGREDIENT
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INDICATIONS & USAGE
Helps prevent sunburns. If used as directed with other sun protection measures decreases the risk of skin cancer and skin aging caused by the sun. Sun Protection Measures: Spending time on the sun increases your risk of skin cancer and skin aging. To decrease the risk regulary use Broad Spectrum Sunscreen with SPF 15 or higher and other protective measures including: limit time in sun, especially from 10am to 2 pm, and wear long-sleeved shirts, pants, hats ans sunglasses.
- WARNINGS
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
Water, Caprylic/Capric Triglyceride, Dimethicone, Ethyhexyl Palmitate, Sorbitan Sesquioleate, Glycerin, Glyceryl Isostearate, Butyrospermum PARKII (Shea Butter), Polyglyceryl-3 Ricinoleate, Helianthus Annuus (Sunflower) Seed Oil (1), Simmondsia Chinensis (Jojoba) Seed Oil (1), Vitis Vinifera(Grape) Seed Oil, Aloe Barbadensis Leaf Juice (1), Calendula Officinalis Flower Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Tocopheryl Acetate, Alcohol, Magnesium Sulfate, Polyxydroxystearic Acid, Silica, Sodium Chloride, Benzyl Alcohol, Phenoxyethanol.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALBA BOTANICA KIDS MINERAL SUNSCREEN FF SPF30
zinc oxide, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-2088 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 14.5 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2 g in 100 g Inactive Ingredients Ingredient Name Strength SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) PHENOXYETHANOL (UNII: HIE492ZZ3T) SHEA BUTTER (UNII: K49155WL9Y) POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALCOHOL (UNII: 3K9958V90M) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ETHYLHEXYL PALMITATE (UNII: 2865993309) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) ALOE (UNII: V5VD430YW9) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) SODIUM CHLORIDE (UNII: 451W47IQ8X) CHAMOMILE (UNII: FGL3685T2X) SUNFLOWER OIL (UNII: 3W1JG795YI) GRAPE SEED OIL (UNII: 930MLC8XGG) BENZYL ALCOHOL (UNII: LKG8494WBH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61995-2088-4 113 g in 1 TUBE; Type 0: Not a Combination Product 03/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/01/2017 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(61995-2088)
