Label: COCO AND EVE DAILY RADIANCE PRIMER SPF 50 lotion

  • 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

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients
    Avobenzone 3%
    Homosalate 8%
    Octisalate 5%
    Octocrylene 6%
    Purpose
    Sunscreen
    Sunscreen
    Sunscreen
    Sunscreen
  • 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

    Warnings

    For external use only.

    Store below 30°C / 86°F and avoid direct sunlight.

    Do not use on damaged or broken skin.

    Stop use and ask a doctor if rash occurs.

    Keep out of reach of children. When using this product keep out of eyes. Rinse with water to remove.

  • 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.
    • 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.
  • 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

    Other Information

    Protect the product from excessive heat and direct sun.

    Questions? Contact (626) 616-5811

  • PRINCIPAL DISPLAY PANEL

    COCO & EVE

    DAILY RADIANCE

    PRIMER SPF 50

    UVA + UVB

    Broad Spectrum

    SPF 50

    Net 50 mL / e 1.69 fl. oz. US

    FIGURE1

    COCO & EVE

    DAILY RADIANCE

    PRIMER SPF 50

    UVA + UVB

    Broad Spectrum

    SPF 50

    Net 50 mL / e 1.69 fl. oz. US

    FIGURE2

  • INGREDIENTS AND APPEARANCE
    COCO AND EVE DAILY RADIANCE PRIMER SPF 50 
    coco and eve daily radiance primer spf 50 lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82931-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE8 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE6 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorPINK (Pale pink) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82931-002-501 in 1 CARTON04/01/2023
    150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/01/2023
    Labeler - Supernova USA Inc. (116909952)