Label: VERY EMOLLIENT BODY DAILY SHADE SPF15- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 61995-0371-1
- Packager: The Hain Celestial Group
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 20, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
For sunscreen use, apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use water resistant sunscreen when swimming or sweating. Children under 6 months: ask a doctor. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with Broad Spectrum SPF 15 or higher and other protective measures, including: limit time in sun, especially 10am-2pm, and wear long-sleeved shirts, pants, hats and sunglasses.
- WARNINGS
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Water (Aqua), Glycerin, Glyceryl Stearate SE, Carthamus Tinctorius (Safflower) Seed Oil, Cetyl Alcohol, Dimethicone, Cetearyl Alcohol, Sesamum Indicum (Sesame) Seed Oil, Butyrospermum Parkii (Shea) Butter, Persea Gratissima (Avocado) 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, Echinacea Angustifolia Extract (1), Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract (1), Ascorbic Acid, Panthenol, Tocopheryl Acetate, Allantoin, Citric Acid, Glycolic Acid, Lactic Acid, Lecithin, Polysorbate 60, Potassium Hydroxide, Xanthan Gum, Alcohol (1), Benzoic Acid, Dehydroacetic Acid, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Amyl Cinnamal, Benzyl Alcohol, Benzyl Salicylate, Butylphenyl Methylpropional, Coumarin, Geraniol, Hexyl Cinnamal, Limonene, Linalool, Fragrance (Parfum)
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
VERY EMOLLIENT BODY DAILY SHADE SPF15
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-0371 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 POLYSORBATE 60 (UNII: CAL22UVI4M) JOJOBA OIL (UNII: 724GKU717M) DEHYDROACETIC ACID (UNII: 2KAG279R6R) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) LACTIC ACID (UNII: 33X04XA5AT) ALCOHOL (UNII: 3K9958V90M) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) SAFFLOWER OIL (UNII: 65UEH262IS) CETYL ALCOHOL (UNII: 936JST6JCN) DIMETHICONE 100 (UNII: RO266O364U) ALOE VERA LEAF (UNII: ZY81Z83H0X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) COUMARIN (UNII: A4VZ22K1WT) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) BENZYL ALCOHOL (UNII: LKG8494WBH) HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q) LAVANDULA ANGUSTIFOLIA WHOLE (UNII: 51217XIL5L) SHEA BUTTER (UNII: K49155WL9Y) HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP) PHENOXYETHANOL (UNII: HIE492ZZ3T) XANTHAN GUM (UNII: TTV12P4NEE) GRAPE SEED OIL (UNII: 930MLC8XGG) PANTHENOL (UNII: WV9CM0O67Z) GLYCOLIC ACID (UNII: 0WT12SX38S) ALLANTOIN (UNII: 344S277G0Z) LIMONENE, (+/-)- (UNII: 9MC3I34447) AVOCADO OIL (UNII: 6VNO72PFC1) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SESAME OIL (UNII: QX10HYY4QV) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) ASCORBIC ACID (UNII: PQ6CK8PD0R) .ALPHA.-HEXYLCINNAMALDEHYDE, (2E)- (UNII: E9947QRR9O) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) GERANIOL (UNII: L837108USY) LINALOOL, (+/-)- (UNII: D81QY6I88E) BENZYL SALICYLATE (UNII: WAO5MNK9TU) MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) CUCUMBER (UNII: YY7C30VXJT) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) Product Characteristics Color white (White to pale off-white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61995-0371-1 340 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 07/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 07/01/2019 Labeler - The Hain Celestial Group (117115556) Registrant - The Hain Celestial Group (014334364) Establishment Name Address ID/FEI Business Operations The Hain Celestial Group 081512382 manufacture(61995-0371)