Label: CVS PHARMACY ILLUMINATING- 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 June 14, 2013

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  • 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 USING THIS PRODUCT 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 CANACER 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, CETEARYL ALCOHOL, DIMETHICONE, GLYCINE SOJA (SOYBEAN) SEED EXTRACT, GLYCERIN, BIS-PHENYLPROPYL DIMETHICONE, ARACHIDYL ALCOHOL, PHENOXYETHANOL, CETEARYL GLUCOSIDE, PANTHENOL, BENZYL ALCOHOL, ETHYLENE/ACRYLIC ACID COPOLYMER, BEHENYL ALCOHOL, STEARETH-2, FRAGRANCE (PARFUM), STEARETH-21, POLYACRYLAMIDE, POLYMETHYL METHACRYLATE, ARACHIDYL GLUCOSIDE, DISODIUM EDTA, METHYLPARABEN, C13-14 ISOPARAFFIN, ETHYLPARABEN, BUTYLPARABEN, LAURETH-7, BENZALKONIUM CHLORIDE, PROPYLPARABEN, ISOBUTYLPARABEN, BHT, IODOPROPYNYL BUTYLCARBAMATE, MICA, SILICA, TITANIUM DIOXIDE.

  • QUESTIONS OR COMMENTS?

    1-800-746-7287

  • LABEL COPY

    IMAGE OF THE LABEL

  • LABEL COPY

    IMAGE OF THE LABEL CARTON

  • INGREDIENTS AND APPEARANCE
    CVS PHARMACY  ILLUMINATING
    avobenzone, octinoxate, octisalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-602
    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)  
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE PEG-15 ACETATE (UNII: 11034H9BGQ)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    TRIMETHYLOLPROPANE TRIACRYLATE (UNII: 4B67KGL96S)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    METHYL METHACRYLATE (UNII: 196OC77688)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    LAURETH-7 (UNII: Z95S6G8201)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    MICA (UNII: V8A1AW0880)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-602-001 in 1 CARTON
    1NDC:59779-602-04118 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/10/2013
    Labeler - CVS PHARMACY (062312574)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture(59779-602)
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