Label: AFFINIA FACIAL MOISTURIZER- avobenzone, homosalate, octisalate, octocrylene lotion

  • NDC Code(s): 54473-224-01, 54473-224-04
  • Packager: Melaleuca, 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 January 4, 2023

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  • Active ingredients

    Avobenzone 1.8%, Homosalate 6%, Octisalate 3%, Octocrylene 5%

  • 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

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

    Stop use and ask a doctor is rash occurs.

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

  • Directions

    For sunscreen use:

    • apply smoothly on cleansed skin

    • apply liberally 15 mintues before sun exposure

    • use a water-resistant sunscreen if swimming or sweating

    • reapply at least every 2 hours

    • children under 6 months: Ask a doctor

    • Sun-Protection measures. 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: • limit time in the sun, especially from 10a.m.-2p.m. • wear long-sleeve shirts, pants, hats, and sunglasses

  • Other information

    • for normal-to-dry skin

    • dermatologist and allergy tested

    • may stain some fabrics

    • protect this product from excessive heat and direct sun

    • do not store at temperatures below 32°F (0°C) or above 120°F (49°C)

    Inactive ingredients

    Ammonium Acryloyldimethyltaurate/VP Copolymer, Aqua (Water/Eau), Butyrospermum Parkii (Shea Butter), Calcium Pantothenate, Cetyl Alcohol, Citric Acid, Dimethicone, Glycerin, Glyceryl Stearate, Maltodextrin, Mangifera Indica (Mango) Seed Butter, Methylisothiazolinone, Niacinamide, Parfum, PEG-100 Stearate, Phenoxyethanol, Phenoxyethyl Caprylate, Polyacrylate-15 (and) Polyacrylate-17, Potassium Sorbate, Pyridoxine HCL, Silica, Sodium Ascorbyl Phosphate, Sodium Starch Octenylsuccinate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Trisodium Ethylenediamine Disuccinate, Xanthan Gum

  • PRINCIPAL DISPLAY PANEL

    Image of box

  • INGREDIENTS AND APPEARANCE
    AFFINIA  FACIAL MOISTURIZER
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-224
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7.296 g  in 120 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE6.08 g  in 120 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3.648 g  in 120 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.1888 g  in 120 mL
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PHENOXYETHYL CAPRYLATE (UNII: GMI5AN7T8U)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    SHEANUT OIL (UNII: O88E196QRF)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54473-224-041 in 1 BOX01/01/2018
    1NDC:54473-224-01120 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/01/2012
    Labeler - Melaleuca, Inc. (139760102)
    Registrant - Melaleuca, Inc. (139760102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Melaleuca, Inc.079711683manufacture(54473-224)
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