Label: FACE BALM SPF-15- avobenzone, homosalate, octisalate, octocrylene lotion

  • 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 March 29, 2022

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  • ACTIVE INGREDIENTS

    AVOBENZONE (3.0%)

    HOMOSALATE (5.0%)

    OCTISALATE (3.0%)

    OCTOCRYLENE (3.0%)

  • PURPOSE

    SUNSCREEN

  • USES

    Apply to cleansed skin, gently smoothing over the face and neck. For best results, follow the complete Urth Skin Solutions regimen. Appliquer sur une peau nettoyee en lissant delicatement le visage et le cou. Pour de meilleurs resultats, suivez le regime complet d'Urth Skin Solutions.

  • CAUTION/ ATTENTION

    For external use only. Avoid eye contact. Store in cool, dry area. Pour usage externe suelement. Eviter le contact des yeaus. Conserver dans un endroit frais et sec.

  • INACTIVE INGREDIENTS

    Water (Aqua), Propylene Glycol, Cetearyl Alcohol, Cetearyl Glucoside, Carthamus Tinctorus (Safflower) Seed Oil, Stearic Acid, Cetyl Alcohol, Ethylhexyl Glycerin, Xanthan Gum, Carbomer, Citrus Aurantium Dulcis (Orange) Peel Oil, Sodium Hydroxide, Sodium Hyaluronate, Niacinamide, Camellia Sinensis (White Tea) Leaf Extract, Ascorbic Acid (Vit. C), Tocopheryl Acetate (Vit.E), Aloe Barbadensis Leaf Extract, Panex Ginseng Extract, Salix Alba (Willow) Bark Extract, Citrus Aurantium Bergamia (Bergamot) Peel Oil, Eucalyptus Globulus Leaf Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Avena Sativa (Oat) Kernel Flour, Phenoxyethanol.

  • FACE BALM SPF-15

    01b_LBL_Face Balm SPF 15_4oz.jpg

  • INGREDIENTS AND APPEARANCE
    FACE BALM SPF-15 
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50518-203
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION20 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    LANOLIN (UNII: 7EV65EAW6H)  
    JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    GERANIOL (UNII: L837108USY)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    EUGENOL (UNII: 3T8H1794QW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50518-203-11118 mL in 1 JAR; Type 0: Not a Combination Product07/06/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/06/2021
    Labeler - CUSTOM RESEARCH LABS (028611598)
    Establishment
    NameAddressID/FEIBusiness Operations
    CUSTOM RESEARCH LABS028611598manufacture(50518-203)
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