Label: SUN PROTECTION- lanolin, avobenzone, octinoxate ointment

  • NDC Code(s): 82806-002-01
  • Packager: MAKRA KOZMETIKA D.O.O.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 21, 2023

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredients

    Lanolin 24.91%

    Avobenzone 2.5%

    Octinoxate 7%

  • Purposes

    Skin Protectant

    Sunscreen

    Sunscreen

  • Uses

    • temporarily protects minor:
    • temporarily protects chapped or cracked skin
    • helps protect from the drying effects of wind and cold weather
    • helps prevent sunburn
    • if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun Directions

    • cuts

    • scrapes

    • burns

  • Warnings

    For external use only.

    Do not use

    • on damaged skin
    • on deep or punture wounds
    • on animal bites
    • on serious burns

    When using this product

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

    Stop use and ask a doctor if

    • rash occurs
    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days

    Keep out of reach of children.

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

  • Directions

    • apply generously 15 minutes before sun exposure
    • reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating
    • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Sun Protection Measures.
    • children under 6 months of age: ask a doctor

    • limit time in the sun, especially from 10 a.m.-2 p.m.

    • wear long-sleeved shirts, pants, hats, and sunglasses

  • Inactive ingredients

    Water, petrolatum, chocolate (Theobroma cacao) butter, calendula (Calendula officinalis) flower extract, almond (Prunus dulcis) oil, cetearyl alcohol, jojoba (simmondsia chinesis) seed oil,sodium benzoate, potassium sorbate, bisbolol, allantoin, tocopheryl acetate, sodium cetearyl sulfate, coumarin, sodium lauryl sulfate, linalool, citric acid, fragrance, cinnamyl alchohol, benzyl salicylate, geraniol.

  • Tattoo Care Sun Protection Sunscreen and Skin Protectant Ointment SPF 30+, 1.4 oz (40g) 82806-200-01

    Tattoo Care Sun Protection Sunscreen and Skin Protectant Ointment SPF 30+, 1.4 oz (40g) 82806-200-01 outer imageTattoo Care Sun Protection Sunscreen and Skin Protectant Ointment SPF 30+, 1.4 oz (40g) 82806-200-01 inner image

  • INGREDIENTS AND APPEARANCE
    SUN PROTECTION 
    lanolin, avobenzone, octinoxate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82806-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN249.1 mg  in 1 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE25 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE70 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    ALLANTOIN (UNII: 344S277G0Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
    COUMARIN (UNII: A4VZ22K1WT)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CINNAMYL ALCOHOL (UNII: SS8YOP444F)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    GERANIOL (UNII: L837108USY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82806-002-011 in 1 CARTON09/01/2022
    140 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01609/01/2022
    Labeler - MAKRA KOZMETIKA D.O.O. (537064093)
    Registrant - MAKRA KOZMETIKA D.O.O. (537064093)
    Establishment
    NameAddressID/FEIBusiness Operations
    MAKRA KOZMETIKA D.O.O.537064093manufacture(82806-002)