Label: SUNFROG ULTRA SPF 30 LIP BALM- octinoxate, octocrylene, oxybenzone, octisalate, petroleum jelly stick

  • 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 November 8, 2022

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  • Active ingredient

    Octinoxate (7.5%), Octocrylene (7.0%), Oxybenzone (5.0%), Octisalate (5.0%), Petrolatum (30.0%)

  • Purpose

    Sunscreen, Sunscreen, Sunscreen, Sunscreen, Skin Protectant

  • Keep Out of Reach of Children

    If swallowed get medical help or contact a Poison Control Center right away.

  • Uses

    Prevents Sunburns

  • 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 aging.

    For external use only: Stop use and ask a doctor: if rash or irritation develops and lasts.

  • Directions

    Apply liberally before sun exposure and as needed. Children under 6 months of age: Ask a doctor before use.

  • Inactive Ingredients

    Synthetic Beeswax, Cetyl Alcohol, Mineral Oil, Paraffin, Polyethylene, Flavor, Caprylic/Capric Triglyceride, Titanium Dioxide (CI 77891), Stearic Acid, Aluminum Hydroxide, Lanolin, Phenyl Trimethicone, Oleyl Alcohol, Isopropyl Lanolate, Isopropyl Myristate, BHT, Tocopheryl Acetate, Propyl paraben, Aloe Barbadensis Leaf Extract, Methylparaben, Sodium Saccharin.

  • Package/Label Principal Display Panel

    Sunfrog Ultra SPF 30 Lip Balm
  • INGREDIENTS AND APPEARANCE
    SUNFROG ULTRA SPF 30 LIP BALM 
    octinoxate, octocrylene, oxybenzone, octisalate, petroleum jelly stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63645-165
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mg  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5.0 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM30.0 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7.0 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.0 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LIGHT MINERAL OIL (UNII: N6K5787QVP) 7.0 mg  in 1 g
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) .1 mg  in 1 g
    WHITE WAX (UNII: 7G1J5DA97F) 16.8 mg  in 1 g
    CETYL ALCOHOL (UNII: 936JST6JCN) 7.0 mg  in 1 g
    METHYLPARABEN (UNII: A2I8C7HI9T) 0.1 mg  in 1 g
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorVANILLAImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63645-165-011 g in 1 CONTAINER; Type 0: Not a Combination Product11/29/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/29/2017
    Labeler - OraLabs (801824756)
    Registrant - OraLabs (801824756)
    Establishment
    NameAddressID/FEIBusiness Operations
    OraLabs801824756MANUFACTURE(63645-165) , LABEL(63645-165)
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