ALBA EVEN ADVANCED SEA MOSS MOISTURIZER SPF15- homosalate, ethylhexyl salicylate, octocrylene, butyl methoxydibenzoylmethane lotion

Alba Even Advanced Sea Moss Moisturizer SPF15 by

Drug Labeling and Warnings

Alba Even Advanced Sea Moss Moisturizer 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]

ACTIVE INGREDIENT

Active Ingredient

Homosalate - 7.5%

Octocrylene -3.0%

Ethylhexyl Salicylate - 5.0%

Butyl Methoxydibenzoylmethane - 2.0%

DOSAGE & ADMINISTRATION

Apply liberally after cleansing and toning and 15 minutes before sun exposure. Reapply every 2 hours during sun exposure.

PURPOSE

Sunscreen

WARNINGS

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

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

INACTIVE INGREDIENT

Water, Glycerin, Glyceryl Stearate SE, Cetyl Alcohol, VP/Hexadecene Copolymer, Caprylic/Capric Triglyceride, Hydrogenated Palm Cernel Oil, Aloe Barbadensis Leaf Juice(1), Camellia Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Chondrus Crispus Extract (1), (2), Enteromorpha Compressa Extract, Laminaria Digitata Extract, Macrocystis Pyrifera Extract, Spirulina Maxima Extract, Ulva Lactuca Extract (1), Allantoin, Ascorbic Acid, Ascorbyl Glucoside, Caesalpinia Spinosa Gum, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Olivate, , Lecithin, Diacetyl Boldine, Erythritol, Homarine HCL, Panthenol, Gluconolactone, Sodium Chloride, Sodium Stearoyl Glutamate, Sorbitan Olivate, Tocopheryl Acetat, Xanthan Gum, Alcohol (1), Benzyl Alcohol, Ethylhexylglycerin, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate.

(1) Certified Organicf Ingredient, (2) Sea Moss Extract

INDICATIONS & USAGE

Helps prevents sunburns. If used 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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALBA EVEN ADVANCED SEA MOSS MOISTURIZER SPF15 
homosalate, ethylhexyl salicylate, octocrylene, butyl methoxydibenzoylmethane lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-2031
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HOMARINE HYDROCHLORIDE (UNII: 8866LNG61N)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALCOHOL (UNII: 3K9958V90M)
ULVA LACTUCA (UNII: PHR3P25W6Y)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CETYL ALCOHOL (UNII: 936JST6JCN)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CHAMOMILE (UNII: FGL3685T2X)
XANTHAN GUM (UNII: TTV12P4NEE)
HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SORBITAN OLIVATE (UNII: MDL271E3GR)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)
DIACETYL BOLDINE (UNII: 37727Z7M0I)
ERYTHRITOL (UNII: RA96B954X6)
PANTHENOL (UNII: WV9CM0O67Z)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
ULVA COMPRESSA (UNII: SXZ209FM33)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
SPIRULINA MAXIMA (UNII: 9K7IG15M0Q)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBIC ACID (UNII: PQ6CK8PD0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-2031-2	1 in 1 CARTON	01/13/2014
1		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/13/2014

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

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

Establishment
Name	Address	ID/FEI	Business Operations
The Hain Celestial Group, Inc.		858894996	manufacture(61995-2031)