Label: AL0038400 ALBA BOTANICA FAST FIX SUN SPF30- octocrylene, octyl salicylate, zinc oxide stick
- NDC Code(s): 61995-2384-1
- 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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- ACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
Caprylic/Capric Trigluceride, Cocos Nucifera (Cococnut) Oil (1), Euphorbia Cerifera (Candelilla) Wax, Jojoba Esters, Glycerin, Hydrogenated Glyceryl Abietate, Glyceryl Behenate, Copernicia Cerifera (Carnauba) Wax, Cetearyl Alcohol, Raphanus Sativus (Radish) Seed Oil, Aloe Barbadensis Leaf Juice(1), Chamomilla Recutita (Matricaria) Flower Extract (1), Butyrospermum Parkii (Shea) Butter (1), Polysorbate 60, Tocopheryol, Theobroma Cacao (Cocoa) Seed Butter (1), Punica Granatum Seed Oil (1), Helianthus Annuus (Sunflower)Seed Oil, Natural Flavor, Citrus Aurantifolia (Lime) Oil,Euterpe Oleracea Fruit Extract (1), Panax Ginseng Root Extract.
(1) Certified Organicf Ingredient
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INDICATIONS & USAGE
Helps prevents sunburns. If uses 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.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AL0038400 ALBA BOTANICA FAST FIX SUN SPF30
octocrylene, octyl salicylate, zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-2384 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 20 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 Inactive Ingredients Ingredient Name Strength TOCOPHEROL (UNII: R0ZB2556P8) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) SHEA BUTTER (UNII: K49155WL9Y) CHAMOMILE (UNII: FGL3685T2X) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POLYSORBATE 60 (UNII: CAL22UVI4M) GLYCERYL MONOBEHENATE (UNII: A626UU0W2A) CARNAUBA WAX (UNII: R12CBM0EIZ) COCOA BUTTER (UNII: 512OYT1CRR) SUNFLOWER OIL (UNII: 3W1JG795YI) PUNICA GRANATUM SEED OIL (UNII: 0UI45XV0T6) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) COCONUT OIL (UNII: Q9L0O73W7L) CANDELILLA WAX (UNII: WL0328HX19) GLYCERYL ABIETATE (UNII: 2F22LY70Q1) HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58) RAPHANUS SATIVUS VAR. SATIVUS SEED (UNII: A94I086Q5E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61995-2384-1 1 in 1 CARTON 12/26/2017 1 14 g in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/26/2017 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(61995-2384)
