AL0038400 ALBA BOTANICA FAST FIX SUN SPF30- octocrylene, octyl salicylate, zinc oxide stick 
The Hain Celestial Group, Inc.

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.

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Alba Botanica Fast Fix Sun Stick SPF 30

Active Ingredient

Octyl Salicylate - 5.0%

Octocrylene - 10.0%

Zinc Ohide - 20.0%

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel dryingt and at least every 2 hours. Children under 6 months: ask a doctor.

Sunscreen

For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if skin rash occurs.

Keep out of reach of children. If swallowed get medical help or contact Poison Center right away.

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

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.

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AL0038400 ALBA BOTANICA FAST FIX SUN SPF30 
octocrylene, octyl salicylate, zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-2384
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61995-2384-11 in 1 CARTON12/26/2017
114 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/26/2017
Labeler - The Hain Celestial Group, Inc. (117115556)
Registrant - The Hain Celestial Group, Inc. (014334364)
Establishment
NameAddressID/FEIBusiness Operations
The Hain Celestial Group, Inc.081512382manufacture(61995-2384)

Revised: 2/2021
Document Id: ba9fa82f-d6df-782c-e053-2995a90a7317
Set id: 614301bd-f735-5ede-e053-2991aa0ae3be
Version: 3
Effective Time: 20210205
 
The Hain Celestial Group, Inc.