Label: FACE VALUES SPF 15 FACIAL MOISTURIZER- octinoxate, octisalate, oxybenzone lotion

  • NDC Code(s): 63940-073-04, 63940-073-05
  • Packager: HARMON STORES, INC.
  • Category: HUMAN OTC DRUG LABEL

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 24, 2021

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  • Active ingredients

    Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 3.0%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
  • Warnings

    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

    For external use only

  • DO NOT USE

    Do not use • on damaged or broken skin

  • WHEN USING

    When using this product • keep out of eyes. Rinse with water to remove.

  • ASK DOCTOR

    Stop use and ask a doctor if • rash occurs

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • 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
  • Other information

    • protect this product from excessive heat and direct sun
    • may stain or damage some fabrics, materials or surfaces
  • Inactive ingredients

    water, octyldodecyl neopentanoate, glycerin, cetearyl alcohol, polysorbate 60, glyceryl stearate, PEG-100 stearate, dimethicone, triethanolamine, diazolidinyl urea, methylparaben, ethylparaben, propylparaben, carbomer

  • Questions or comments?

    Call toll free 1-800-527-7731

  • PRINCIPAL DISPLAY PANEL

    FACE VALUES OIL-FREE SPF 15 MOISTURIZING LOTION

    4 FL OZ (118mL)

    NDC 63940-069-04

    LabelFrontLabelBack

    FACE VALUES OIL-FREE SPF 15 MOISTURIZING LOTION

    BLISTER PACK

    NDC 63940-069-05

    Blister Pack

  • INGREDIENTS AND APPEARANCE
    FACE VALUES SPF 15 FACIAL MOISTURIZER 
    octinoxate, octisalate, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-073
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE30 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63940-073-051 in 1 CARTON03/08/2013
    1NDC:63940-073-04118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/08/2013
    Labeler - HARMON STORES, INC. (804085293)
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