Label: AMISH ORIGINS SPF 15 LIP BALM- octinoxate, octocrylene, oxybenzone 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 April 6, 2017

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  • Active ingredient

    Octinoxate (7.5%), Octocrylene (2.0%), Oxybenzone (4.0%)

  • Purpose

    Sunscreen, Sunscreen, Sunscreen

  • 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

    Petrolatum, Mineral Oil, Paraffin, Euphorbia Cerifera ( Candelilla) Wax, Theobroma Cacao (Cocoa) Seed Butter, Menthol, Propylene Glycol, Eucalyptus Globulus (Eucalyptus) Oil, Abies Sibirica Oil, Methyl Salicylate, Cinnamomum Camphora (Camphor) Bark Oil, Isopropyl Myristate, Tocopheryl Acetate, Aloe Barbadenis Leaf Extract, Paraffin, Methylparaben.

  • Package/Label Principal Display Panel

    Amish Origins SPF 15 Front and Back of Card
  • INGREDIENTS AND APPEARANCE
    AMISH ORIGINS SPF 15 LIP BALM 
    octinoxate, octocrylene, oxybenzone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62212-350
    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) OXYBENZONE4.0 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.0 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U) 27.0 mg  in 1 g
    LIGHT MINERAL OIL (UNII: N6K5787QVP) 25.5 mg  in 1 g
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) .29 mg  in 1 g
    CANDELILLA WAX (UNII: WL0328HX19) 8.0 mg  in 1 g
    MENTHOL, (+)- (UNII: C6B1OE8P3W) 2.0 mg  in 1 g
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62212-350-011 g in 1 CONTAINER; Type 0: Not a Combination Product08/17/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/17/2015
    Labeler - Amish Origins (079239259)
    Registrant - OraLabs (801824756)
    Establishment
    NameAddressID/FEIBusiness Operations
    OraLabs801824756MANUFACTURE(62212-350) , LABEL(62212-350)
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