Label: TONE BLUR ESSENCE SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene cream
- NDC Code(s): 84326-124-01
- Packager: RBGROUP Co., Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 22, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- OTHER SAFETY INFORMATION
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DOSAGE & ADMINISTRATION
Directions
■ Apply liberally 15 minutes before sun exposure.■ Use a water resistant sunscreen if swimming or swating.
■ Reapply at least every 2 hours.
■ Children under 6 months of age: Ask a doctor.
■ 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 10a.m. - 2 p.m. ■ Wear long-sleeve shirts, pants, hats, and sunglasses.
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INACTIVE INGREDIENT
Water, Butyloctyl Salicylate, Dicaprylyl Carbonate, Cetearyl Alcohol, Cetearyl Glucosidde, Dipropylene Glycol, Sorbitan Olivate, Poly C10-30 Alkyl Acrylate, Polymethylsilsesquioxane, Niacinamide, Benzyl Glycol, Glyceryl Stearate SE, Panthenol, Arginine, Carbomer, Tocopherol, Butylene Glycol, Xanthan Gum, Hydroxypropyl Methylcellulose Stearoxy Ether, Ethylhexylglycerin, Glycerin, Adenosine, Ethyl Hexanediol, 1,2-Hexanediol, Centella Asiatica Extract, Madecassic Acid, Asiaticoside, Asiatic Acid, Aloe Barbadensis Leaf Juice, Sodium Hyaluronate
- PDP_Tone Blur Essence Sunscreen
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INGREDIENTS AND APPEARANCE
TONE BLUR ESSENCE SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84326-124 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.5 g in 50 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.5 g in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 4.35 g in 50 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 5 g in 50 mL Inactive Ingredients Ingredient Name Strength BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) ADENOSINE (UNII: K72T3FS567) ASIATIC ACID (UNII: 9PA5A687X5) .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U) NIACINAMIDE (UNII: 25X51I8RD4) ETHYLENE GLYCOL MONOBENZYL ETHER (UNII: 06S8147L47) GLYCERIN (UNII: PDC6A3C0OX) MADECASSIC ACID (UNII: M7O1N24J82) HYPROMELLOSE 2208 0.45% STEAROXY ETHER (UNII: MG58AH4FJ8) POLYACRYLIC ACID (800000 MW) (UNII: D0I6NSZ87U) ASIATICOSIDE (UNII: PKO39VY215) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) ARGININE (UNII: 94ZLA3W45F) HYALURONATE SODIUM (UNII: YSE9PPT4TH) WATER (UNII: 059QF0KO0R) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) SORBITAN OLIVATE (UNII: MDL271E3GR) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) XANTHAN GUM (UNII: TTV12P4NEE) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J) ALOE VERA LEAF (UNII: ZY81Z83H0X) DIPROPYLENE GLYCOL (UNII: E107L85C40) PANTHENOL (UNII: WV9CM0O67Z) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) ETHOHEXADIOL (UNII: M9JGK7U88V) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84326-124-01 50 mL in 1 TUBE; Type 0: Not a Combination Product 05/14/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/14/2024 Labeler - RBGROUP Co., Ltd (987610097) Establishment Name Address ID/FEI Business Operations reBom Co., Ltd 695951708 manufacture(84326-124)
