Label: NO-AD SPF 8 TANNING- octinoxate, octisalate 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 4, 2014

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  • Active Ingredients

    Octinoxate 4.5%
    Octisalate 5.0%

  • 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 on damaged or broken skin.  Stop use and ask a doctor if rash occurs.  When using this product keep out of eyes.  Rinse with water to remove.  Keep out of the reach of children.  If swallowed, get medical help or call a poison control center right away.

  • Directions

    • apply evenly and liberally to all exposed areas 15 minutes before sun exposure.  Ensure skin is completely covered with product.
    • reapply after 40 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours
    • children under 6 months:  Ask a doctor
  • Other Information

    • protect this product from excessive heat and direct sun
    • for use on skin only
    • avoid contact with fabric
  • PRINCIPAL DISPLAY PANEL

    image of carton label

  • INGREDIENTS AND APPEARANCE
    NO-AD SPF 8 TANNING 
    octinoxate, octisalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62802-210
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4.5 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CANOLA OIL (UNII: 331KBJ17RK)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CARROT SEED OIL (UNII: 595AO13F11)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62802-210-16475 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2012
    Labeler - Sun & Skin Care Research, LLC (849772207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sun & Skin Care Research, LLC849772207manufacture(62802-210)
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