Label: ANTI-AGING DAILY MOISTURIZER SUNSCREEN BROAD-SPECTRUM SPF 30- avobenzone, octinoxate, octisalate, oxybenzone cream

  • NDC Code(s): 61016-0003-2
  • Packager: Columbia Cosmetics Manufacturing, Inc.
  • 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 November 29, 2018

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

  • Drug Facts
  • Purpose

    Sunscreen

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  • Active ingredients:

    AVOBENZONE (3.0%)
    OCTINOXATE (7.5%)
    OCTISALATE (5.0%)
    OXYBENZONE (4.0%)

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  • Uses:

    • helps prevent sunburn
    • if used as directed with other sun protection measure (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun.
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  • Warnings:

    For external use only

    Do not use

    on damaged or broken skin.

    Stop use and ask a doctor

    if rash occurs.

    When using this product

    keep out of eyes.  Rinse with water to remove.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions:

    • apply liberally 15 minutes before sun exposure
    • use a water-resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • children under 6 months: 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 10 AM to 2 PM
    • wear long-sleeved shirts, pants, hats and sunglasses.
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  • Inactive ingredients:

    WATER (AQUA), ISOPROPYL PALMITATE, ISOEICOSANE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, POTASSIUM CETYL PHOSPHATE, GLYCERIN, CETYL DIMETHICONE, ETHYHEXYL METHOXYCRYLENE, SILICA, DIMETHICONE, POLYGLYCERYL-3 DIISOSTEARATE, CETEARYL ALCOHOL, HYDROXYETHYLCELLULOSE, PHENOXYETHANOL, GLYCERYL STEARATE, PEG-100 STEARATE, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, HEXYLENE GLYCOL, TETRAHEXYLDECYL ASCORBATE, TOCOPHERYL ACETATE, BUTYLENE GLYCOL, CAMELIA OLEIFERA LEAF EXTRACT, PUNICA GRANATUM FRUIT EXTRACT.

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  • Other information:

    • protect this product from excessive heat and direct sun.
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  • PRINCIPAL DISPLAY PANEL

    Anti-Aging Daily Moisturizer  Sunscreen Broad-Spectrum SPF 30  Paraben-free  Sulfate-free    2.0 FL OZ  59mL   MADE IN USA   A light easily absorbed SPF day creme formulated with Antioxidants and Extracts of White Tea and Pomegranate.

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  • Anti-Aging Daily Moisturizer Sunscreen Broad-Spectrum SPF 30 2oz/59ml (61016-0003-2)
  • INGREDIENTS AND APPEARANCE
    ANTI-AGING DAILY MOISTURIZER SUNSCREEN BROAD-SPECTRUM SPF 30 
    avobenzone, octinoxate, octisalate, oxybenzone cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:61016-0003
    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 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 40 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    ISOEICOSANE (UNII: AR294KAG3T)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61016-0003-2 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/19/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 04/19/2012
    Labeler - Columbia Cosmetics Manufacturing, Inc. (068267863)
    Establishment
    Name Address ID/FEI Business Operations
    Columbia Cosmetics Manufacturing, Inc. 068267863 manufacture(61016-0003)
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