Label: DAILY MOISTURIZING BROAD SPECTRUM SPF15 SUNSCREEN- avobenzone, homosalate, octinoxate, 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 September 10, 2013

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  • Active ingredient

    Avobenzone 3.0%

    Homosalate 3.0%

    Octisalate 5.0%

    Octocrylene 10.0%

  • 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.

     

    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.

    If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • 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 of age: 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 the product in this container from excessive heat and direct sun
  • Inactive Ingredients

    water, glycerin, polyethylene, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, polysorbate 60, dimethicone, cetyl alcohol, cetearyl alcohol, cetearyl glucoside, panthenol (pro-vitamin B5), niacinamide, phenoxyethanol, methylparaben, ethylparaben, propylparaben, stearyl alcohol, cyclopentasiloxane, dimethiconol, behenyl alcohol, tocopheryl acetate (vitamin E), DMDM hydantoin, benzyl alcohol, PEG-4 dilaurate, stearic acid, PEG-100 stearate, fragrance, disodium EDTA

  • Package/Label Principal Display Panel

    Image Essentials® Daily Moisturizer

    • For Normal Skin
    • Light, Non-greasy
    • With Vitamin E & Pro-Vitamin B5

     

    Compare to Olay® Complete
    All Day UV Moisturizer SPF 15
    Normal Skin Ingredients*

    SPF 15 Broad Spectrum Sunscreen

    4 FL OZ (118 mL)

    *This product is not made or distributed by Procter & Gamble, owner of the registered trademark Olay® Complete.

    Distributed by:
    Kmart Corporation
    Hoffman Estates, IL 60179
    Shop kmart.com

    Manufactured in Israel
    1D626 AF C1

    Kmart Daily Moisturizer

    Carton Label

  • INGREDIENTS AND APPEARANCE
    DAILY MOISTURIZING BROAD SPECTRUM SPF15 SUNSCREEN 
    avobenzone, homosalate, octinoxate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49738-626
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE3 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PEG-4 DILAURATE (UNII: KCR71CW036)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49738-626-111 in 1 CARTON
    1118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/10/2013
    Labeler - Kmart Corporation (008965873)
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