Label: ALBA BOTANICA KIDS SUNSCREENTROPICAL FRUIT SPF45- avobenzone, homosalate, octocrylene, octyl salicylate lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 61995-2099-4 - 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
- DOSAGE & ADMINISTRATION
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
Water, Cetyl Alcohol, Glycerin,Glyceryl Stearate SE, Dimethicone, Caprylic/Capric Triglyceride, VP/Hexadecene Copolymer, Cetearyl Alcohol, Citrus Aurantium Dulcis (Orange) Peel Oil, Glycine Soja (Soybean) Oil, Aloe Barbadensis Leaf Juice(1), Calendula Officinalis Flower Extract (1), Camellia Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Ginkgo Biloba Leaf Extract, Lavandula Angustifolia (Lavender) Extract (1), Panax Ginseng Root Extract, Tocopheryl Acetate, Alcohol (1), A-Terpinyl Acetate, Cetearyl Alcohol, Cetearyl Olivate, Citric Acid, Dimethylhydroxy Furanone, Nonanal, Polysorbate 60, Sodium Chloride, Sodium Stearoyl Glutamate, Sorbitan Olivate, Vanillin, Xanthan Gum, Benzyl Alcohol, Potassium Sorbate, Sodium Benzoate, Limonene.
(1) Certified Organic 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.
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INGREDIENTS AND APPEARANCE
ALBA BOTANICA KIDS SUNSCREENTROPICAL FRUIT SPF45
avobenzone, homosalate, octocrylene, octyl salicylate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-2099 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g Inactive Ingredients Ingredient Name Strength .ALPHA.-TERPINYL ACETATE, (+/-)- (UNII: 9RXE0I9F2J) LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) ALCOHOL (UNII: 3K9958V90M) BENZYL ALCOHOL (UNII: LKG8494WBH) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) ORANGE OIL (UNII: AKN3KSD11B) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ASIAN GINSENG (UNII: CUQ3A77YXI) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SOYBEAN OIL (UNII: 241ATL177A) CETYL ALCOHOL (UNII: 936JST6JCN) DIMETHICONE (UNII: 92RU3N3Y1O) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CHAMOMILE (UNII: FGL3685T2X) XANTHAN GUM (UNII: TTV12P4NEE) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POLYSORBATE 60 (UNII: CAL22UVI4M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) GINKGO (UNII: 19FUJ2C58T) CETEARYL OLIVATE (UNII: 58B69Q84JO) SODIUM CHLORIDE (UNII: 451W47IQ8X) SORBITAN OLIVATE (UNII: MDL271E3GR) SODIUM BENZOATE (UNII: OJ245FE5EU) DIMETHYLHYDROXY FURANONE (UNII: 20PI8YZP7A) NONANAL (UNII: 2L2WBY9K6T) LIMONENE, (+/-)- (UNII: 9MC3I34447) VANILLIN (UNII: CHI530446X) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61995-2099-4 113 g in 1 TUBE; Type 0: Not a Combination Product 10/11/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/11/2017 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(61995-2099)
