Label: ALBA BOTANICA VE DAILY SHADE SPF15 BODY- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 61995-2072-9
- 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 April 12, 2021
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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, Potassium Sorbate, Sodium Benzoate.
(1) Certified Organicf Ingredient
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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.
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INGREDIENTS AND APPEARANCE
ALBA BOTANICA VE DAILY SHADE SPF15 BODY
avobenzone, homosalate, octisalate, octocrylene lotionProduct 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. (081512382) Establishment Name Address ID/FEI Business Operations The Hain Celestial Group, Inc. 081512382 manufacture(61995-2072)
