Label: HAMPTON SUN- octinoxate, oxybenzone gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 – 4.00%

    Oxybenzone - 2.00%

  • PURPOSE

    Octinoxate – 4.00%..................Sunscreen

    Oxybenzone - 2.00%...............Sunscreen

  • INDICATIONS & USAGE


    Uses • Helps prevent sunburn​

  • WARNINGS

    Warnings

    Skin cancer/Skin Aging alert

    For external use only

    Do not use on Damage or broken skin

    When using this product 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 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, Cyclohexasiloxane, Cyclopentasiloxane

    Dimethicone Crosspolymer, Ethylhexyl Palmitate, Fragrance, Hydrogenated Polyisobutene, Hydrolyzed Jojoba Esters, Jojoba Esters, Juglans Regia (Walnut) Seed Oil, Mineral Oil, Sorbitan Olivate, Tocopheryl Acetate, Water

  • PRINCIPAL DISPLAY PANEL

    SPF 4 OIL

  • INGREDIENTS AND APPEARANCE
    HAMPTON SUN 
    octinoxate, oxybenzone gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72667-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE (UNII: V5VD430YW9)  
    BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    WALNUT OIL (UNII: Y0P3555R51)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    C12-15 ALCOHOLS (UNII: 2C8M6XLB5C)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS) (UNII: CH428W5O62)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72667-012-01118 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/01/2019
    Labeler - Inspec Solutions LLC. (081030372)
    Establishment
    NameAddressID/FEIBusiness Operations
    Inspec Solutions LLC.081030372manufacture(72667-012)
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