Label: REVIVE SOLEIL SUPERIEUR BROAD SPECTRUM SPF 50 SUNSCREEN PA- avobenzone, homosalate, octisalate, and octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 58411-420-10 - Packager: RéVive Skincare
- 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 January 18, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
- 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
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Sun Protection Measures. 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
- Other information
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Inactive ingredients
Aqua/Water/Eau, Caprylyl Methicone, Dipropylene Glycol, Dicaprylyl Carbonate, PEG/PPG-17/6 Copolymer, Potassium Cetyl Phosphate, Thermus Thermophillus Ferment, Glyceryl Stearate, PEG-100 Stearate, Methyl Glucose Sesquistearate, SD Alcohol 40-B, Hydrogenated Palm Glycerides, Oligopeptide-24, Silybin, Carnosine, Adenosine, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Cetyl Alcohol, Isohexadecane, Phenoxyethanol, Panthenol, Caprylyl Glycol, Polyacrylate-15, PEG-10 Dimethicone, Tocopheryl Acetate, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Lecithin, Polygonum Aviculare Extract, Polyacrylate-17, Polysorbate 80, Potassium Sorbate, Potassium Hydroxide, Hexylene Glycol, C11-15 Pareth-40, C11-15 Pareth-7, Dipotassium Glycyrrhizate, Fragrance (Parfum), Sorbitan Oleate, Sodium Benzoate, Disodium Lauryl Sulfosuccinate, Sodium Laureth-12 Sulfate.
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 50 g Bottle Carton
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INGREDIENTS AND APPEARANCE
REVIVE SOLEIL SUPERIEUR BROAD SPECTRUM SPF 50 SUNSCREEN PA
avobenzone, homosalate, octisalate, and octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-420 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 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 26 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPROPYLENE GLYCOL (UNII: E107L85C40) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) PEG/PPG-17/6 COPOLYMER (UNII: P5QZM4T259) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D) ALCOHOL (UNII: 3K9958V90M) HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q) SILIBININ (UNII: 4RKY41TBTF) CARNOSINE (UNII: 8HO6PVN24W) ADENOSINE (UNII: K72T3FS567) SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX) CETYL ALCOHOL (UNII: 936JST6JCN) ISOHEXADECANE (UNII: 918X1OUF1E) PHENOXYETHANOL (UNII: HIE492ZZ3T) PANTHENOL (UNII: WV9CM0O67Z) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GLYCERIN (UNII: PDC6A3C0OX) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) HEXYLENE GLYCOL (UNII: KEH0A3F75J) C11-15 PARETH-40 (UNII: L774F88277) C11-15 PARETH-7 (UNII: 261HPE0IS3) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) SODIUM BENZOATE (UNII: OJ245FE5EU) DISODIUM LAURYL SULFOSUCCINATE (UNII: P160Q81342) SODIUM LAURETH-12 SULFATE (UNII: 8M492LDU23) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-420-10 1 in 1 CARTON 02/01/2016 1 50 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 02/01/2016 Labeler - RéVive Skincare (193691821)
