Label: COCO AND EVE DAILY RADIANCE PRIMER SPF 50 lotion
- NDC Code(s): 82931-002-50
- Packager: Supernova USA Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 March 31, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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INDICATIONS & USAGE
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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DOSAGE & ADMINISTRATION
Directions
- Apply generously and evenly as the last step in your skincare routine, before makeup and 20 minutes before sun exposure.
- Reapply frequently especially after swimming, sweating or towelling.
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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 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-sleeve shirts, pants, hats, and sunglasses.
- Children under 6 months: ask a doctor.
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INACTIVE INGREDIENT
Inactive Ingredients Water/Aqua, Butyloctyl Salicylate, Polyester-8, Diisopropyl Sebacate, Ethylhexyl Methoxycrylene, Propanediol, Glyceryl Stearate, Sodium Potassium Aluminum Silicate, Silica, Pentylene Glycol, Disodium Cetearyl Sulfosuccinate, Niacinamide, Glycerin, Camellia Sinensis Leaf Extract, Pelargonium Capitatum Leaf Extract, Tocopherol, Caprylic/Capric Triglyceride, Tocopheryl Acetate, Phenylpropanol, Diethylhexyl Syringylidenemalonate, Sodium Polyacryloyldimethyl Taurate, Caprylyl Glycol, Xanthan Gum, Trimethoxybenzylidene Pentanedione, Phytic Acid, Cl 77891/Titanium Dioxide, Cl 771633/Bismuth Oxychloride, Cl 77491/Iron Oxides, Sodium Hydroxide.
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COCO AND EVE DAILY RADIANCE PRIMER SPF 50
coco and eve daily radiance primer spf 50 lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82931-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 8 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 6 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) PROPANEDIOL (UNII: 5965N8W85T) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) SODIUM POTASSIUM ALUMINUM SILICATE (UNII: Z6C6FF3Y9R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PENTYLENE GLYCOL (UNII: 50C1307PZG) DISODIUM STEARYL SULFOSUCCINATE (UNII: 45FC88252P) GLYCERIN (UNII: PDC6A3C0OX) PHENYLPROPANOL (UNII: 0F897O3O4M) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) NIACINAMIDE (UNII: 25X51I8RD4) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) SODIUM POLYACRYLOYLDIMETHYL TAURATE (UNII: NG5NG5733T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CAPRYLYL GLYCOL (UNII: 00YIU5438U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) XANTHAN GUM (UNII: TTV12P4NEE) TRIMETHOXYBENZYLIDENE PENTANEDIONE (UNII: 322V0ACF25) FYTIC ACID (UNII: 7IGF0S7R8I) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) FERRIC OXIDE RED (UNII: 1K09F3G675) PELARGONIUM CAPITATUM LEAF (UNII: 7P4L8U253X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) TOCOPHEROL (UNII: R0ZB2556P8) SODIUM HYDROXIDE (UNII: 55X04QC32I) Product Characteristics Color PINK (Pale pink) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82931-002-50 1 in 1 CARTON 04/01/2023 1 50 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 final part352 04/01/2023 Labeler - Supernova USA Inc. (116909952)