ALBA BOTANICA VE DAILY SHADE SPF15 BODY- avobenzone, homosalate, octisalate, octocrylene lotion

Alba Botanica VE Daily Shade SPF15 Body by

Drug Labeling and Warnings

Alba Botanica VE Daily Shade SPF15 Body 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 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, Glycerin,Glyceryl Stearate SE, Carthamus Tinctorius(Safflower) Seed Oil, Cetyl Alcohol, Dimethicone, Cetearyl Alcohol, Hydrogenated Palm Cernel Oil, Persea Gratissima (Avocado) Oil, Sesamum Indicum (Sesame) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil (1), Vitis Vinifera (Grape) Seed Oil, Aloe Barbadensis Leaf Juice(1), Camellia Sinensis, Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Cucumis Sativus (Cucumber) Fruit Extract, Lavandula Angustifolia (Lavender) Extract, Echinacea Purpurea Extract, Allantoin, Ascorbic Acid, Butyrospermum Parkii (Shea) Butter, Lactic Acid, Glycolic Acid, Lecithin, Panthenol, Polysorbate 60, Tocopheryl Acetat, Xanthan Gum, Alcohol (1),Benzoic Acid, Dehydroacetic Acid, Benzyl Alcohol, Phenoxyethanol, 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 VE DAILY SHADE SPF15 BODY 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-2072
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)
LACTIC ACID (UNII: 33X04XA5AT)
ALCOHOL (UNII: 3K9958V90M)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SHEA BUTTER (UNII: K49155WL9Y)
ECHINACEA PURPUREA ROOT (UNII: OS64WTR4KU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
SAFFLOWER OIL (UNII: 65UEH262IS)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALLANTOIN (UNII: 344S277G0Z)
BENZOIC ACID (UNII: 8SKN0B0MIM)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
AVOCADO OIL (UNII: 6VNO72PFC1)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CHAMOMILE (UNII: FGL3685T2X)
CUCUMBER (UNII: YY7C30VXJT)
XANTHAN GUM (UNII: TTV12P4NEE)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GRAPE SEED OIL (UNII: 930MLC8XGG)
LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)
GLYCOLIC ACID (UNII: 0WT12SX38S)
HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)
SESAME OIL (UNII: QX10HYY4QV)
JOJOBA OIL (UNII: 724GKU717M)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PANTHENOL (UNII: WV9CM0O67Z)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-2072-9	907 g in 1 BOTTLE; Type 0: Not a Combination Product	04/11/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/11/2017

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(61995-2072)