ALBA BOTANICA EVEN ADVANCED MOISTURIZER SPF15- avobenzone, homosalate, octisalate, octocrylene lotion

Alba Botanica Even Advanced Moisturizer SPF15 by

Drug Labeling and Warnings

Alba Botanica Even Advanced 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

Avobenzone 2.0%

Homosalate 7.5%

Octisalate 5.0%

Octocrylene 3.0%

DOSAGE & ADMINISTRATION

For sunscreen use apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen when swimming or sweating.

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, Caprylic/Capric Triglcerides, Glycerin,Glyceryl Stearate SE, Carthamus Tinctorius(Safflower) Seed Oil, Cetyl Alcohol, , Cetearyl Olivate, Cetearyl Olivate, Sorbitan Olivate, Hydrogenated Palm Cernel Oil, Aloe Barbadensis Leaf Juice(1), Camellia Sinensis, Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Chrondrus Crispus Extract, Allantoin, Ascorbic Acid, Ascorbyl Glucoside Lecithin, Panthenol, Tocopheryl Acetat, Xanthan Gum, Alcohol (1),Benzyl Alcohol, VP/Hexadecene, Ethylhexylglycerin Phenoxyethanol, Gluconolactone, Diacetyl Boldine, Potassium Sorbate, Sodium Benzoate.

(1) Certified Organicf Ingredient

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 BOTANICA EVEN ADVANCED MOISTURIZER SPF15 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-2012
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
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SPIRULINA MAXIMA (UNII: 9K7IG15M0Q)
DIACETYL BOLDINE (UNII: 37727Z7M0I)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)
ERYTHRITOL (UNII: RA96B954X6)
HOMARINE HYDROCHLORIDE (UNII: 8866LNG61N)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
ULVA COMPRESSA (UNII: SXZ209FM33)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
SORBITAN OLIVATE (UNII: MDL271E3GR)
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
ULVA LACTUCA (UNII: PHR3P25W6Y)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
ALCOHOL (UNII: 3K9958V90M)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
SAFFLOWER OIL (UNII: 65UEH262IS)
ALLANTOIN (UNII: 344S277G0Z)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CHAMOMILE (UNII: FGL3685T2X)
XANTHAN GUM (UNII: TTV12P4NEE)
HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PANTHENOL (UNII: WV9CM0O67Z)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-2012-2	1 in 1 CARTON	08/17/2016
1		57 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	08/17/2016

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(61995-2012)