Label: ATTITUDE - LIP BALM - SPF 15 - COCONUT- zinc oxide stick

  • NDC Code(s): 61649-985-01
  • Packager: Attitude DBA 9055-7588 Québec Inc.
  • 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 July 29, 2022

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Medicinal ingredient

    Zinc oxide (10%)

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • Warnings

    For external use only.

    Do not use on damaged or broken skin. If rash occurs, stop use and ask a doctor.

    When using this product keep out of eyes. Rinse with water to remove.

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

  • Directions

    Apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours. Reapply after eating or drinking. FOR EXTERNAL USE ONLY.

  • Inactive or non-medicinal ingredients

    cocos nucifera (coconut) oil, polyhydroxystearic acid, butyrospermum parkii (shea) butter, helianthus annuus (sunflower) seed oil, helianthus annuus (sunflower) seed wax, behenyl behenate, caprylic/capric triglyceride, ricinus communis (castor) seed oil, argania spinosa kernel oil, euphorbia cerifera (candelilla) wax, coco-caprylate/caprate, rosmarinus officinalis (rosemary) leaf extract, gamma-octalactone1, gamma-nonalactone1, vanillin1, ethyl hexanoate1, ethyl acetate1.

    1
    flavour
  • Other Information

    Store at temperatures below 90°F.

  • PRINCIPAL DISPLAY PANEL - 8.5 g Tube Carton

    PLASTIC FREE

    ATTITUDE™
    natural care

    15
    SPF

    lip balm
    COCONUT

    VEGAN
    OCEAN LOVERS™

    NPN 80109103 ∙ 8.5 g / 0.3 OZ.

    PRINCIPAL DISPLAY PANEL - 8.5 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    ATTITUDE - LIP BALM - SPF 15 - COCONUT 
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61649-985
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    BEHENYL BEHENATE (UNII: K8NU647RJ0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
    ROSEMARY (UNII: IJ67X351P9)  
    VANILLIN (UNII: CHI530446X)  
    .GAMMA.-OCTALACTONE (UNII: UHD6M52X0K)  
    .GAMMA.-NONALACTONE (UNII: I1XGH66S8P)  
    ETHYL CAPROATE (UNII: FLO6YR1SHT)  
    ETHYL ACETATE (UNII: 76845O8NMZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61649-985-018.5 g in 1 TUBE; Type 0: Not a Combination Product08/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35202/04/2022
    Labeler - Attitude DBA 9055-7588 Québec Inc. (201137051)
    Establishment
    NameAddressID/FEIBusiness Operations
    Attitude DBA 9055-7588 Québec Inc.204307099MANUFACTURE(61649-985) , LABEL(61649-985) , PACK(61649-985) , ANALYSIS(61649-985)
    Establishment
    NameAddressID/FEIBusiness Operations
    Attitude DBA 9055-7588 Québec Inc.201137051MANUFACTURE(61649-985) , ANALYSIS(61649-985)
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