Label: EQUALINE ALL DAY MOISTURIZER- octisalate, avobenzone, homosalate, octocrylene lotion

  • 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 March 18, 2013

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  • ACTIVE INGREDIENTS

    OCTISALATE 5.0%, AVOBENZONE 3.0%, HOMOSALATE 3.0%, OCTOCRYLENE 2.6%

    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. 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 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:

    ASCORBIC ACID, BEHENYL ALCOHOL, BENZYL ALCOHOL, CETEARYL ALCOHOL, CETEARYL GLUCOSIDE, CETYL ALCOHOL, DIMETHICONE, DIMETHICONOL, DISODIUM EDTA, ETHYLPARABEN, FRAGRANCE (PARFUM), GLYCERIN, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, IODOPROPYNYL BUTYLCARBAMATE, ISOHEXADECANE, METHYLPARABEN, PANTHENOL, PENTYLENE GLYCOL, NIACINAMIDE, PEG-4, PEG-4 DILAURATE, PEG-4 LAURATE, PEG-100 STEARATE, POLYETHYLENE, POLYSORBATE 60, PROPYLPARABEN, STEARIC ACID, STEARYL ALCOHOL, TOCOPHERYL ACETATE, WATER (AQUA).

  • QUESTIONS OR COMMENTS?

    1-877-932-7948

  • LABEL COPY

    IMAGE OF THE LABEL

  • INGREDIENTS AND APPEARANCE
    EQUALINE  ALL DAY MOISTURIZER
    octisalate, avobenzone, homosalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-356
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE30 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE26 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J)  
    PEG-4 DILAURATE (UNII: KCR71CW036)  
    PEG-4 LAURATE (UNII: AYF4VM3N1Z)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41163-356-06178 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/15/2013
    Labeler - SUPERVALU INC. (006961411)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture(41163-356)
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