Label: THEFACESHOP NATURAL SUN OIL-FREE SUNSCREEN BROAD SPECTRUM SPF 50- ensulizole, octinoxate, octisalate, titanium dioxide, zinc oxide 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 December 13, 2021

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  • ACTIVE INGREDIENTS

    Ensulizole 3.5%
    Octinoxate 7.00%
    Octisalate 4.5%
    Titanium Dioxide 4.57%
    Zinc Oxide 11.65%

  • 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

    Do not use ​on damaged or broken skin

  • WHEN USING

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

  • STOP USE

    Stop use and ask doctor if rash occurs

  • KEEP OUT OF REACH OF CHILDREN

    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 and as needed.
    • Reapply as needed or after towel drying, 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 the sun, especially from 10 a.m. to 2 p.m.

    - Wear long-sleeved shirts, pants, hats, and sunglasses

    • Children under 6 months: Ask a doctor
  • INACTIVE INGREDIENTS

    WATER, CYCLOPENTASILOXANE, DIPROPYLENE GLYCOL, GLYCERIN, DICAPRYLYL CARBONATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TROMETHAMINE, DIMETHICONE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, PANTHENOL, DISTEARDIMONIUM HECTORITE, ALUMINUM HYDROXIDE, ZINC STEARATE, SORBITAN SESQUIOLEATE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, STEARIC ACID, GLYCERYL CAPRYLATE, HYDROGEN DIMETHICONE, DISTEARYLDIMONIUM CHLORIDE, ETHYLHEXYLGLYCERIN, TRIETHOXYCAPRYLYLSILANE, TRISODIUM EDTA, HELIANTHUS ANNUS (SUNFLOWER) SRPOUT EXTRACT, MENTHYL PCA, SODIUM PCA, SODIUM BENZOATE, TITANIUM DIOXIDE (CI 77891), FRAGRANCE

  • OTHER INFORMATION

    Protect this product from excessive heat and direct sun

  • QUESTIONS OR COMMENTS?

    Call toll free 1-888-498-9004

  • PRINCIPAL DISPLAY PANEL NATURAL SUN OIL-FREE SUNSCREEN BROAD SPECTRUM SPF 50 1.69 fl. oz. 50 mL

    natural sun oil free

  • INGREDIENTS AND APPEARANCE
    THEFACESHOP NATURAL SUN OIL-FREE SUNSCREEN BROAD SPECTRUM SPF 50 
    ensulizole, octinoxate, octisalate, titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72330-195
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.5 g  in 50 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5.825 g  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.25 g  in 50 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.285 g  in 50 mL
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE1.75 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
    MENTHYL DL-PYRROLIDONECARBOXYLATE (UNII: 8P18J856U2)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72330-195-012 in 1 BOX01/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2018
    Labeler - fmg Co.Ltd (690188305)
    Registrant - LG HOUSEHOLD & HEALTH CARE LTD (688276187)
    Establishment
    NameAddressID/FEIBusiness Operations
    fmg Co.Ltd690188305manufacture(72330-195)
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