Label: SUN SCREENLOTION SPF30 01- octinoxate,avobenzone,oxybenzone,titanium dioxide lotion

  • NDC Code(s): 54860-417-01
  • Packager: Shenzhen Lantern Scicence Co.,Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 18, 2023

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  • Active Ingredient

    ETHYLHEXYL METHOXYCINNAMATE：8.5%

    Avobenzone：3.0%

    Titanium dioxide：3.0%

    Sunscreen

  • Inactive ingredients

    AQUA, METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHE NOL, AQUA, DECYL GLUCOSIDE, PROPYLENE GLYCOL, XANTHAN GUM, GLYCERIN, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, ETHYLHEXYL TRIAZONE, DIMETHICONE, PEG-20 METHYL GLUCOSE SESQUISTEARATE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, METHYL GLUCOSE SESQUISTEARATE, PHENOXYETHANOL, TOCOPHERYL ACETATE, PARFUM, MENTHOL, METHYLPARABEN, BISABOLOL, ALLANTOIN, PROPYLPARABEN, DISODIUM EDTA, SPIRULINA PLATENSIS EXTRACT, SODIUM HYALURONATE.

  • Directions

    Apply liberaaly 15 minutes before sun exposure.

    Children under 6 months; Ask a doctor.

    When using this product

    keep out of eyes. In case of contact with eyes, flush thoroughly with water.

    Do not inhale or ingest.

    Avoid contact with broken skin.

    Other information

    Do not store above 105F.

    May discolor some fabrics.

    Harmful to wood finishes and plastics.

  • When using this product

    Keep out of eyes,Rinse with water to remove.

  • Purpose

    Sunscreen

  • Stop use and ask a doctor

    if rash occurs.

  • Do not use

    on danaged or broken skin.

  • Other information

    Protect the product in this container from excessive heat and direct sun.

    For sunscreen use

    Apply to all skin exposed to the sun

    Limit time in the sun,especially from 10 a.m.-2 p.m.

    Wear long-s;eeved shirts,pants,hats,and sunglasses.

  • Warnings

  • Warnings

    For external use only

  • DOSAGE & ADMINISTRATION SECTION

    Emulsion，Apply generously 15 minutes before sun exposure

    Reapply at least every 2 hours

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Packaging

    PackagingPackaging

  • INGREDIENTS AND APPEARANCE
    SUN SCREENLOTION SPF30  01
    octinoxate,avobenzone,oxybenzone,titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54860-417
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE8.5 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCYRRHIZA URALENSIS (UNII: 42B5YD8F0K)  
    CAPRYLIC/CAPRIC/PALMITIC/STEARIC TRIGLYCERIDE (UNII: ZF29F7IK5I)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    ENZACAMENE (UNII: 8I3XWY40L9)  
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    CETEARETH-25 (UNII: 8FA93U5T67)  
    .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54860-417-0145 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/19/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/19/2023
    Labeler - Shenzhen Lantern Scicence Co.,Ltd. (421222423)
    Registrant - LANTERN HEALTH&BEAUTY LAB INC. (086860340)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Lantern Science Co.,Ltd.421222423manufacture(54860-417)
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