Label: SOLEIL SUPERIEUR BODY SPF 50 US- avobenzone, homosalate, octisalate, octocrylene cream
- NDC Code(s): 82691-145-00
- Packager: RV Skincare LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 6, 2023
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- Drug Facts
- Active ingredients
- Uses
- Warnings
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Directions
• For sunscreen use: • apply liberally 15 minutes before sun exposure • use a water resistant sunscreen if swimming or sweating • reapply at least every 2 hours • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses • Children under 6 months of age: Ask a doctor
Sun Protection Measures. - Other information
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Inactive ingredients:
Aqua (Water, Eau), Ethylhexyl Salicylate, Dipropylene Glycol, Caprylyl Methicone, Dicaprylyl Carbonate, PEG/PPG-17/6 Copolymer, Potassium Cetyl Phosphate, PEG-100 Stearate, Glyceryl Stearate, Methyl Glucose Sesquistearate, Alcohol Denat., Oligopeptide-24, Tocopheryl Acetate, Caprylyl Glycol, Polyacrylate-15, PEG-10 Dimethicone, Carnosine, Lecithin, Polyacrylate-17, Silybin, Tocopherol, Glycerin, Sodium Oleate, Glycine Soja (Soybean) Oil, Hydrogenated Lecithin, Hexylene Glycol, C11-15 Pareth-7, C11-15 Pareth-40, Parfum (Fragrance), Sodium Laureth-12 Sulfate, Disodium Lauryl Sulfosuccinate, Hydrogenated Palm Glycerides, Cetyl Alcohol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Disodium EDTA, Potassium Sorbate, Potassium Hydroxide, Citric Acid.
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INGREDIENTS AND APPEARANCE
SOLEIL SUPERIEUR BODY SPF 50 US
avobenzone, homosalate, octisalate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82691-145 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 26 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPROPYLENE GLYCOL (UNII: E107L85C40) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) PEG/PPG-17/6 COPOLYMER (UNII: P5QZM4T259) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) PEG-100 STEARATE (UNII: YD01N1999R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D) ALCOHOL (UNII: 3K9958V90M) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CARNOSINE (UNII: 8HO6PVN24W) SILIBININ (UNII: 4RKY41TBTF) TOCOPHEROL (UNII: R0ZB2556P8) GLYCERIN (UNII: PDC6A3C0OX) SODIUM OLEATE (UNII: 399SL044HN) SOYBEAN OIL (UNII: 241ATL177A) HEXYLENE GLYCOL (UNII: KEH0A3F75J) C11-15 PARETH-7 (UNII: 261HPE0IS3) C11-15 PARETH-40 (UNII: L774F88277) SODIUM LAURETH-12 SULFATE (UNII: 8M492LDU23) DISODIUM LAURYL SULFOSUCCINATE (UNII: P160Q81342) HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q) CETYL ALCOHOL (UNII: 936JST6JCN) PHENOXYETHANOL (UNII: HIE492ZZ3T) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82691-145-00 1 in 1 CARTON 04/01/2020 1 120 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 04/01/2020 Labeler - RV Skincare LLC (080986653)