Label: AGELESS SOLAR DEFENSE (SPF 30)- octinoxate, octisalate, oxybenzone, avobenzone cream

  • 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 January 31, 2023

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  • Drug Facts

  • Active ingredients

    Octinoxate 7.5%
    Octisalate 5.0%
    Oxybenzone 4.0%
    Avobenzone 3.0%

    Purpose

    Sunscreen

  • 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

    • For external use only.

    Do not use

    • on damaged or broken skin.

    Stop use and contact your doctor if

    • rash occurs.

    Keep out of reach of children.

    • If swallowed, get medical help, or contact a poison control center right away.

    • Do not apply too closely to the eye area. Rinse with water to remove.

  • Directions

    • Apply liberally to face and body at least 15 minutes before sun exposure or two minutes before applying makeup.
    • Reapply:
    • After 80 minutes of swimming or sweating
    • Immediately after towel drying.
    • At least every 2 hours.
    • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and 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 specially, from 10 a.m. - 2 p.m.
    • Wear long sleeved shirts, pants, hats and sunglasses.

    • Children under 6 months of age: Ask a doctor.

  • Other information

    • Protect the product in this container from excessive heat and direct sun.
  • Inactive ingredients

    Water (Aqua), Isopropyl Palmitate, Isoeicosane, Potassium Cetyl Phosphate, Glycerin, Ethylhexyl Methoxycrylene, Silica, Cetyl Dimethicone, Hydroxyethylacrylate/sodium acryloyldimethyl taurate copolymer, Dimethicone, Polyglyceryl-3 Diisostearate, Cetearyl Alcohol, Polysorbate 60, Isohexadecane, Hydroxyethylcellulose, Phenoxyethanol, Glyceryl Stearate, PEG-100 Stearate, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Butylene Glycol, Punica Granatum (Pomegranate) Extarct, Camellia Oleifera Leaf Extract

  • Questions or Comments?

    Contact us at: contact@audiaskincare.com

    Monday - Friday (9am - 5pm PST)

    Dist-by Divine 369 LLC. San Francisco CA, 94124

    www.audiaskincare.com

  • Package Labeling:

    Label0

  • INGREDIENTS AND APPEARANCE
    AGELESS SOLAR DEFENSE (SPF 30) 
    octinoxate, octisalate, oxybenzone, avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82084-0011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE40 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    ISOEICOSANE (UNII: AR294KAG3T)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    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)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82084-0011-050 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/15/2021
    Labeler - Divine 369 LLC (081571821)
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