Label: ALBA BOTANICA HAWAIIAN SPF 50 COCONUT- avobenzone, homosalate, octisalate, octocrylene spray
- NDC Code(s): 61995-0389-1, 61995-0389-2, 61995-0389-3
- Packager: Hain Celestial Group, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 16, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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DOSAGE & ADMINISTRATION
Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours. Children under 6 months: ask a doctor. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with broad spectrum SPF 15 or higher and other protective measures including:
- limit time in the sun, especially from 10am to 2pm
- and wear long-sleeved shirts, pants, hats and sunglasses.
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
Alcohol Denat., Butyloctyl Salicylate, Acrylates/Octylacrylamide Copolymer, Fragrance (Parfum), Aloe Barbadensis Leaf Extract, Camellia Sinensis Leaf Extract, Carthamus Tinctorius (Safflower) Seed Oil, Chamomilla Recutita (Matricaria) Flower Extract, Diisopropyl Adipate, Ginkgo Biloba Leaf Extract, Helianthus Annuus (Sunflower) Seed Oil, Panax Quinquefolius Root Extract, Persea Gratissima (Avocado) Oil, Tocopheryl Acetate, Coumarin, Limonene, Linalool.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALBA BOTANICA HAWAIIAN SPF 50 COCONUT
avobenzone, homosalate, octisalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-0389 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7.6 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.9 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.9 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 14.7 g in 100 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) AMERICAN GINSENG (UNII: 8W75VCV53Q) AVOCADO OIL (UNII: 6VNO72PFC1) SUNFLOWER OIL (UNII: 3W1JG795YI) ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK) ALOE VERA LEAF (UNII: ZY81Z83H0X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) SAFFLOWER OIL (UNII: 65UEH262IS) CHAMOMILE (UNII: FGL3685T2X) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) GINKGO (UNII: 19FUJ2C58T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61995-0389-1 148 mL in 1 CAN; Type 0: Not a Combination Product 10/01/2022 2 NDC:61995-0389-2 177 mL in 1 CAN; Type 0: Not a Combination Product 10/01/2022 3 NDC:61995-0389-3 237 mL in 1 CAN; Type 0: Not a Combination Product 10/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 10/01/2022 Labeler - Hain Celestial Group, Inc (117115556)