Label: AL0083103 ALBA HAWAIIAN DRY COCONUT SUNSCREEN SPF15- octisalate, octocrylene, avobenzone oil
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Contains inactivated NDC Code(s)
NDC Code(s): 61995-2083-4 - 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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- WARNINGS AND PRECAUTIONS
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
Carthamus Tinctorius (Safflower) Seed Oil (1), Ethylhexyl Palmitate, Cocos Nucifera (Coconut) Oil (1), Butyrospermum Parkii (Shea) Butter, Citrus Aurantium Dulcis (Orange) Peel Oil, Daucus Carota Sativa (Carrot) Seed Oil, Juniperus Virginiana Oil, Macadamia Ternifolia Seed Oil, Tocopherol, Tocopheryl Acetate, Phenoxyethanol, Caprylic/Capric Trigluceride, Allyl Caproate, Ethyl Acetate.
(1) Certified Organic Ingredient
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DOSAGE & ADMINISTRATION
Apply liberally before Sun exposure. Reapply after 40 minutes of swimming or sweating, immediately aftertowel 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 cancerand early skin aging.To decrease risk, regulary use 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-sleevedshirts, pants, hats and sunglases.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AL0083103 ALBA HAWAIIAN DRY COCONUT SUNSCREEN SPF15
octisalate, octocrylene, avobenzone oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-2083 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 133 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7.5 g in 133 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 g in 133 g Inactive Ingredients Ingredient Name Strength ETHYLHEXYL PALMITATE (UNII: 2865993309) SAFFLOWER OIL (UNII: 65UEH262IS) COCONUT OIL (UNII: Q9L0O73W7L) SHEA BUTTER (UNII: K49155WL9Y) CARROT SEED OIL (UNII: 595AO13F11) MACADAMIA OIL (UNII: 515610SU8C) TOCOPHEROL (UNII: R0ZB2556P8) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) ORANGE OIL (UNII: AKN3KSD11B) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61995-2083-4 133 g in 1 BOTTLE; Type 0: Not a Combination Product 07/14/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/14/2017 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(61995-2083)
