AL0083103 ALBA HAWAIIAN DRY COCONUT SUNSCREEN SPF15- octisalate, octocrylene, avobenzone oil

AL0083103 Alba Hawaiian Dry Coconut Sunscreen SPF15 by

Drug Labeling and Warnings

AL0083103 Alba Hawaiian Dry Coconut 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.

ACTIVE INGREDIENT

Avobenzone - 2.0%

Octyl Salicylate - 5.0%

Octocrylene - 7.5%

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.

INACTIVE INGREDIENT

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

DOSAGE & ADMINISTRATION

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AL0083103 ALBA HAWAIIAN DRY COCONUT SUNSCREEN SPF15 
octisalate, octocrylene, avobenzone oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-2083
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 133 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7.5 g  in 133 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 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)
ORANGE OIL (UNII: AKN3KSD11B)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-2083-4	133 g in 1 BOTTLE; Type 0: Not a Combination Product	07/14/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/14/2017

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.		117115556	manufacture(61995-2083)