ALBA HAWAIIANDRY SUNSCREEN SPF15- homosalate, 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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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. 

Drug Facts

Homosalate   10%

Ethylhexyl Salicylate   5.0%

Octocrylene  3.0%

Butyl Methoxydibenzoylmethane  2.0%

Purpose: Sunscreen

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

Sun Protection Measures: Spending time

Ethylhexyl Palmitate, Carthamus Tinctorius (Safflower) Seed Oil (1), Cocos Nucifera (Coconut) Oil (1), Butyrospermum Parkii (Shea) Butter, Daucus Carota Sativa (Carrot) Seed Oil, Tocopherol, Tocopherol Acetate, Phenixyethanol, Fragrance.

(1) Certified Organic Ingredient

bottle label

ALBA HAWAIIANDRY SUNSCREEN SPF15 
homosalate, octisalate, octocrylene, avobenzone oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-2102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10.0 g  in 133 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.0 g  in 133 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3.0 g  in 133 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.0 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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61995-2102-4133 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/14/2014
Labeler - The Hain Celestial Group, Inc. (858894996)
Establishment
NameAddressID/FEIBusiness Operations
The Hain Celestial Group, Inc.858894996manufacture(61995-2102)

Revised: 1/2014
Document Id: d013384d-aefb-4661-ab37-0f1860d218d0
Set id: 7b9c57f3-3c99-46a7-a36f-e31aee846bb2
Version: 1
Effective Time: 20140122
 
The Hain Celestial Group, Inc.