AL0083103 ALBA HAWAIIAN DRY COCONUT SUNSCREEN SPF15- octisalate, octocrylene, avobenzone oil 
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 Coconut Dry Oil Sunscreen SPF 15

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.

Avobenzone - 2.0%

Octyl Salicylate - 5.0%

Octocrylene - 7.5%

Purpose: Sunscreen

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

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

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.

bottle label

AL0083103 ALBA HAWAIIAN DRY COCONUT SUNSCREEN SPF15 
octisalate, octocrylene, avobenzone oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-2083
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 133 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7.5 g  in 133 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 133 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61995-2083-4133 g in 1 BOTTLE; Type 0: Not a Combination Product07/14/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/14/2017
Labeler - The Hain Celestial Group, Inc. (117115556)
Registrant - The Hain Celestial Group, Inc. (014334364)
Establishment
NameAddressID/FEIBusiness Operations
The Hain Celestial Group, Inc.081512382manufacture(61995-2083)

Revised: 2/2021
Document Id: baa05746-4160-fa26-e053-2a95a90af63a
Set id: 616b84b8-58c7-2e24-e053-2a91aa0ac110
Version: 3
Effective Time: 20210205
 
The Hain Celestial Group, Inc.