Label: ALBA BOTANICA MAXIMUM SUNSCREEN SPF 70- avobenzone, homosalate, octisalate, octocrylene spray
- NDC Code(s): 61995-3035-1, 61995-3035-2
- Packager: Hain Celestial Group, Inc
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 16, 2023
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Alcohol Denat., Butyloctyl Salicylate, Acrylates/Octylacrylamide Copolymer, Aloe Barbadensis Leaf Extract, Camellia Sinensis Leaf Extract, Carthamus Tinctorius (Safflower) Seed Oil, Chamomilla Recutita (Matricaria) Flower Extract, Diisopropyl Adipate, Ethylhexyl Methoxycrylene, Ginkgo Biloba Leaf Extract, Helianthus Annuus (Sunflower) Seed Oil, Panax Quinquefolius Root Extract, Persea Gratissima (Avocado) Oil, Tocopheryl Acetate
- PURPOSE
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INDICATIONS & USAGE
● Hold container 4 to 6 inches/ from skin to apply ● Spray liberally/generously and spread evenly by hand 15 minutes before sun exposure. Do not spray directly onto face; spray on hands, then apply to face. Do not apply in windy conditions. Use in a well-ventilated area and avoid inhaling or exposing others to spray. ● reapply: ● at least every 2 hours ● after 40 minutes of swimming or sweating
● immediately after towel drying. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: ■ limit time in the sun, especially from 10 am - 2 pm/ 11 a.m. – 3 p.m ■ wear long-sleeved shirts, pants, hats, and sunglasses. ● For use on children under 6 months of age, ask a doctor. - WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALBA BOTANICA MAXIMUM SUNSCREEN SPF 70
avobenzone, homosalate, octisalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-3035 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 9.5 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 PANAX GINSENG ROOT OIL (UNII: P9T4K47OM0) ALCOHOL (UNII: 3K9958V90M) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) AVOCADO OIL (UNII: 6VNO72PFC1) SUNFLOWER OIL (UNII: 3W1JG795YI) ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK) ALOE VERA LEAF (UNII: ZY81Z83H0X) MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) SAFFLOWER OIL (UNII: 65UEH262IS) CAMELLIA OIL (UNII: T1PE06G0VE) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) GINKGO (UNII: 19FUJ2C58T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61995-3035-1 148 mL in 1 CAN; Type 0: Not a Combination Product 01/01/2021 2 NDC:61995-3035-2 177 mL in 1 CAN; Type 0: Not a Combination Product 01/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 01/01/2021 Labeler - Hain Celestial Group, Inc (117115556)
