Label: ILLUMINATING DAILY MOISTURIZER SPF 15- avobenzone, octinoxate, octisalate 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 April 16, 2018

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

  • Active ingredients

    Avobenzone 3%, Octinoxate 7.5%, Octisalate 2%

    Purpose

    Sunscreen

  • Use(s)

    • 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.

    When using this product

    keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if

    rash occurs.

    Keep out of reach of children.

    In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

  • Directions

    • apply liberally 15 minutes before sun exposure.
    • reapply at least every 2 hours.
    • use a water resistant sunscreen if swimming or sweating.
    • 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 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses.
  • Other information

    • protect this product from excessive heat and direct sun.
  • Inactive ingredients

    Water (Aqua), C12-15 Alkyl Benzoate, Diethylhexyl 2,6 Naphthalate, Cetearyl Alcohol, Dimethicone, Glycine Soja (Soybean) Seed Extract, Glyceirn, BIS-Phenylpropyl Dimethicone, Arachidyl Alcohol, Phenoxyethanol, Cetearyl Glucoside, Panthenol, Benzyl Alcohol, Ethylene/Acrylic Acid Copolymer, Behenyl Alcohol, Steareth-2, Fragrance (Parfum), Steareth-12, Polyacrylamide, Nylon 10-10, Arachidyl Glucoside, Disodium EDTA, C13-14 Isoparaffin, Ethylhexylglycerin, Laureth-7, Benzalkonium Chloride, Sodium Hydroxide, Iodopropynyl Butylcarbamate, BHT, Titanium Dioxide (CI 77891), Mica.

  • Label Copy

    Image of the label

  • INGREDIENTS AND APPEARANCE
    ILLUMINATING DAILY MOISTURIZER SPF 15 
    avobenzone, octinoxate, octisalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-601
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BIS-PHENYLPROPYL DIMETHICONE (15 CST) (UNII: 4836494CFT)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    NYLON-12 (UNII: 446U8J075B)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    LAURETH-7 (UNII: Z95S6G8201)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-601-05118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/13/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/13/2018
    Labeler - CVS Pharmacy (062312574)
    Registrant - Apollo Health and Beauty Care Inc. (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc.201901209manufacture(59779-601)