Label: FIRST AID BEAUTY FAB ULTRA REPAIR FACE MOISTURIZER WITH SUNSCREEN BROAD SPECTRUM SPF 30- octocrylene, and zinc oxide lotion

  • NDC Code(s): 69423-691-50
  • Packager: The Procter & Gamble Manufacturing Company
  • 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 March 9, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients

    Octocrylene 10.0%

    Zinc oxide 10.13 %

    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 if

    • rash occurs

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

  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply at least every 2 hours
    • use water resistant sunscreen if swimming or sweating
    • 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 sun, especially from 10 a.m. - 2 p.m.
      • wear long-sleeved shirts, pants, hats, and sunglasses
    • children under 6 months: ask a doctor
  • Other information

    • protect this product from excessive heat and direct sun
  • Inactive ingredients

    water, isononyl isononanoate, glycerin, c13-15 alkane, dimethicone, polyglyceryl-6 stearate, hydroxypropyl starch phosphate, ethylhexyl methoxycrylene, c12-15 alkyl benzoate, polysorbate 20, phenoxyethanol, glyceryl stearate, cetearyl alcohol, hydrogen dimethicone, polyglyceryl-6 behenate, citric acid, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, xanthan gum, isohexadecane, chrysanthemum parthenium (feverfew) extract, camellia sinensis leaf extract, glycyrrhiza glabra (licorice) root extract, polyhydroxystearic acid, polysorbate 60, potassium sorbate, sodium benzoate, sorbitan isostearate, tetrasodium edta

  • Questions?

    888-FAB-3063

  • SPL UNCLASSIFIED SECTION

    MADE IN USA.

    FIRST AID BEAUTY ® LTD
    NEWTON, MA 02458.

    WWW.FIRSTAIDBEAUTY.COM

  • PRINCIPAL DISPLAY PANEL

    First Aid Beauty

    FAB

    ULTRA REPAIR

    FACE

    MOISTURIZER

    WITH SUNSCREEN

    Broad Spectrum

    SPF 30

    SAFE FOR SENSITIVE SKIN

    1.7 FL OZ (50 mL)

    FAB

  • INGREDIENTS AND APPEARANCE
    FIRST AID BEAUTY FAB ULTRA REPAIR FACE MOISTURIZER WITH SUNSCREEN BROAD SPECTRUM SPF 30 
    octocrylene, and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-691
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    HYDROXYPROPYL CORN AMYLOPECTIN, PHOSPHATE CROSSLINKED (4000 MPA.S AT 5%) (UNII: GSS77345H7)  
    C13-15 ALKANE (UNII: 114P5I43UJ)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    TANACETUM PARTHENIUM (UNII: 6GE7Z0761K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    POLYGLYCERYL-6 BEHENATE (UNII: 4T2L7QI313)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-691-501 in 1 CARTON02/14/2023
    150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02002/14/2023
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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