ALBA HAWAIIANDRY SUNSCREEN SPF15- homosalate, octisalate, octocrylene, avobenzone oil

Alba HawaiianDry Sunscreen SPF15 by

Drug Labeling and Warnings

Alba HawaiianDry Sunscreen SPF15 by is a Otc medication manufactured, distributed, or labeled by The Hain Celestial Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS AND PRECAUTIONS

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

Purpose: Sunscreen

KEEP OUT OF REACH OF CHILDREN

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

OTHER SAFETY INFORMATION

Sun Protection Measures: Spending time

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALBA HAWAIIANDRY SUNSCREEN SPF15 
homosalate, octisalate, octocrylene, avobenzone oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-2102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10.0 g  in 133 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.0 g  in 133 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3.0 g  in 133 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.0 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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-2102-4	133 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/14/2014

Labeler - The Hain Celestial Group, Inc. (858894996)

Establishment
Name	Address	ID/FEI	Business Operations
The Hain Celestial Group, Inc.		858894996	manufacture(61995-2102)