Label: ALBA BODY DAILY SHADE SPF15- homosalate, ethylhexyl salicylate, octocrylene, butul methoxydibenzoylmethane lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 61995-2037-9 - Packager: The Hain Celestial Group, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 3, 2014
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- ACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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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.
(1) Certified Organicf Ingredient
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INDICATIONS & USAGE
Helps prevents sunburns. If uses 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.
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INGREDIENTS AND APPEARANCE
ALBA BODY DAILY SHADE SPF15
homosalate, ethylhexyl salicylate, octocrylene, butul methoxydibenzoylmethane lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-2037 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 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:61995-2037-9 907 g in 1 BOTTLE; Type 0: Not a Combination Product 11/11/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/11/2013 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(61995-2037)