Label: ACTIVE RADIANCE DAY MOISTURE SPF 30- avobenzone, octinoxate, octisalate, octocrylene, oxybenzone cream

  • NDC Code(s): 56152-5004-1, 56152-5004-2
  • Packager: COSMETIC ENTERPRISES LTD
  • 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 February 22, 2017

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  • ACTIVE INGREDIENT

    ​Active Ingredients                         Purpose

    Avobenzone 3.0% ........................ Sunscreen

    Octinoxate 5.0% ........................... Sunscreen

    Octisalate 5.0% ............................ Sunscreen

    Octocrylene 2.4% ......................... Sunscreen

    Oxybenzone 5.0% ........................ Sunscreen

  • PURPOSE

    ​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 cause by the sun 
  • KEEP OUT OF REACH OF CHILDREN

    ​Keep out of reach of children. ​If product is swallowed, get medical help or contact a Poison Control Center right away 

  • INDICATIONS & USAGE

    ​Stop use and ask a doctor if ​- rash occurs

  • WARNINGS

    ​Warnings

    • ​For exter use only
    • ​Do not use ​on damaged or broken skin
    • when usign this porduct ​keep out of eyes. Rinse with water to remove
  • DOSAGE & ADMINISTRATION

    ​Directions

    • apply liberally and evenly 15 minutes before sun exposure
    • reapply at least every 2 hours and after towel drying, swimming, or perspiring to avoid lowering sun protection
    • ​Sun Protection Measures ​UV exposure from the sun increase to the risk of skin cancer, premature skin aging and other skin damage. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including limiting time spent in the sun from 10 a.m. - 2 p.m. and wearing protective clothing
    • Children under 6 months: Ask a doctor
  • INACTIVE INGREDIENT

    Water (Aqua), Caprylyl Methicone, C12-15 Alkyl Benzoate, Niacinamide, Butylene Glycol, Glycerin, Steareth-21, Mica, Cetearyl Alcohol, Ethylhexyl Methoxycrylene, Titanium Dioxide, Tocopheryl Acetate, Glycyrrhiza Glabra (Licorice) Root Extract, Phyllanthus Emblica Fruit Extract, Phospholipids, Linoleic Acid, Arachidly Alcohol, Behenyl Alcohol, Arachidyl Glucoside, Cetearyl Glucoside, Boron Nitride, Aluminum Starch Octenylsuccinate, Xanthan Gum, Polyacrylate-13, Polyisobutene, Polysorbate 20, Phenoxyethanol, Chlorphenesin, Pentaerythrityl Tetra-Di-t-Buty Hydroxyhydrocinnamate, Disodium EDTA

  • PRINCIPAL DISPLAY PANEL

    Specific Beauty

    Active Radiance

    Day Moisture

    Broad Spectrum SPF 30

    1.7 FL. OZ. / 50 mL

    box

    Drug Facts - Label

  • INGREDIENTS AND APPEARANCE
    ACTIVE RADIANCE DAY MOISTURE SPF 30 
    avobenzone, octinoxate, octisalate, octocrylene, oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56152-5004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.4 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARETH-21 (UNII: 53J3F32P58)  
    MICA (UNII: V8A1AW0880)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56152-5004-21 in 1 BOX03/01/2017
    1NDC:56152-5004-150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/01/2017
    Labeler - COSMETIC ENTERPRISES LTD (017701475)
    Registrant - COSMETIC ENTERPRISES LTD (017701475)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSMETIC ENTERPRISES LTD017701475manufacture(56152-5004)