Label: HAMPTON SUN- octinoxate, octisalate, oxybenzone spray

  • 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 June 1, 2019

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  • ACTIVE INGREDIENT

    Active Ingredients:

    Octinoxate - 7.50%

    Octisalate - 5.00%

    Oxybenzone - 3.00%

  • PURPOSE

    Octinoxate - 7.50% .....................Sunscreen.

    Octisalate - 5.00% ......................Sunscreen.​

    Oxybenzone - 3.00% ..................Sunscre.en.​

  • INDICATIONS & USAGE

    Use • helps prevent sunburn.

  • WARNINGS

    Warnings

    Skin cancer/Skin Aging alert

    For external use only

    Do noy use on Damage or broken skin

    keep out of eyes. Rinse with water to remove. ​

  • STOP USE


    Stop use and ask a doctor if rash occurs.​

  • KEEP OUT OF REACH OF CHILDREN


    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    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 of age: ask a doctor.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Aloe Barbadensis Leaf Extract, Benzotriazolyl Dodecyl p-Cresol, C12-15 Alkyl Benzoate, Cyclohexasiloxanel, Cyclopentasiloxane

    Dimethicone Crosspolymer, Fragrance, Hydrogenated Polyisobutene, Hydrolyzed Jojoba Esters, Jojoba Esters, Juglans Regia (Walnut) Seed Oil, Mineral OilSorbitan Olivate, Tocopheryl Acetatel, Water

  • PRINCIPAL DISPLAY PANEL

    SPF 8 GEL

  • INGREDIENTS AND APPEARANCE
    HAMPTON SUN 
    octinoxate, octisalate, oxybenzone spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72667-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE (UNII: V5VD430YW9)  
    C12-15 ALCOHOLS (UNII: 2C8M6XLB5C)  
    TRIEPOXYCYCLOHEXASILANE (UNII: 066Q83563R)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS) (UNII: CH428W5O62)  
    WALNUT OIL (UNII: Y0P3555R51)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72667-011-01118 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2019
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/01/2019
    Labeler - Inspec Solutions LLC. (081030372)
    Establishment
    NameAddressID/FEIBusiness Operations
    Inspec Solutions LLC.081030372manufacture(72667-011)
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