Label: FIRST AID BEAUTY FAB BROAD SPECTRUM SUNSCREEN SPF 30- octinoxate, octocrylene, and zinc oxide cream

  • 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 February 3, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients

    Octinoxate 5.6%

    Octocrylene 7.5%

    Zinc oxide 4.8 %

    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, glycerin, dimethicone, caprylic/capric triglyceride, C12-15 alkyl benzoate, hydrogenated lecithin, caprylyl methicone, enteromorpha compressa extract, caesapinia spinosa gum, copaifera officinalis (balsam copaiba) resin, phenoxyethanol, citric acid, phenyl methicone, bisabolol, glycyrrhiza glabra (licorice) root extract, chrysanthemum parthenium (feverfew) extract, hydroxethyl acrylate/sodium acryloyldimethyl taurate copolymer, polyhydroxystearic acid, isohexadecane, methicone, glyceryl polyacrylate, polysilicone-11, xanthan gum, sodium benzoate, potassium sorbate, alpha arbutin, phyllanthus emblica fruit extract, polysorbate 60, hydroxylated lecithin, camellia sinensis leaf extract

  • 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

    Broad Spectrum

    Sunsceren

    SPF 30

    Muiltitasker

    1 Reduce appearance of wrinkles

    2 Help skin tone appear more even

    3 Filter UVA/UVB rays

    4 Nourish and moisturize

    5 Combat surface free radicals

    SAFE FOR SENSITIVE SKIN

    FIRST AID BEAUTY ​®

    1.7 FL OZ (50 mL)

    FAB

  • INGREDIENTS AND APPEARANCE
    FIRST AID BEAUTY FAB BROAD SPECTRUM SUNSCREEN SPF 30 
    octinoxate, octocrylene, and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-603
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5.6 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7.5 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.8 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALPHA-ARBUTIN (UNII: 72VUP07IT5)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    TANACETUM PARTHENIUM (UNII: 6GE7Z0761K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COPAIFERA OFFICINALIS RESIN (UNII: 1VH544O5AT)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ULVA COMPRESSA (UNII: SXZ209FM33)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PHENYL METHICONE (500 CST) (UNII: 5T0F958X3Z)  
    PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-603-501 in 1 CARTON01/01/2021
    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 finalpart35201/01/2021
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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