Label: QUIKSILVER SPF 30 SUNSCREEN 01- avobenzone,ethylhexyl methoxycinnamate,homosalate,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 September 17, 2021

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  • Drug Facts

    54860-382-01.

  • Active Ingredient

    Active Ingredient Purpose

    Avobenzone 1.0%

    Ethylhexyl Methoxycinnamate 8.0%

    Homosalate 2.0%

    Octocrylene 2.0% ..........................................Sunscreen

  • Inactive ingredients

    AQUA,CYCLOPENTASILOXANE,ISOHEXADECANE,ETHYLHEXYL METHOXYCINNAMATE,GLYCERIN,BUTYLENE GLYCOL,CETYL PEG/PPG-10/1 DIMETHICONE,HOMOSALATE,OCTOCRYLENE,SODIUM CHLORIDE,AVOBENZONE,POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE,DISTEARDIMONIUM HECTORITE,PHENOXYETHANOL,HYDROXYACETOPHENONE,PARFUM,BISABOLOL,DISODIUM EDTA.

  • 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.

  • PRINCIPAL DISPLAY PANEL

    54860-382-01

  • INGREDIENTS AND APPEARANCE
    QUIKSILVER SPF 30 SUNSCREEN  01
    avobenzone,ethylhexyl methoxycinnamate,homosalate,octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54860-383
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE2 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE8 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) 1 g  in 100 g
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.4 g  in 100 g
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) 0.5 g  in 100 g
    ROSA RUGOSA FLOWER (UNII: 969IQC5YJU) 0.2 g  in 100 g
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) 0.05 g  in 100 g
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 1 g  in 100 g
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) 0.3 g  in 100 g
    LEVOMENOL (UNII: 24WE03BX2T) 0.1 g  in 100 g
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) 12 g  in 100 g
    ISOHEXADECANE (UNII: 918X1OUF1E) 8 g  in 100 g
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) 2 g  in 100 g
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 3 g  in 100 g
    WATER (UNII: 059QF0KO0R) 53.45 g  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) 5 g  in 100 g
    Product Characteristics
    Colorwhite (opaque) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54860-383-0130 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/14/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/14/2021
    Labeler - Shenzhen Lantern Scicence Co.,Ltd. (421222423)
    Registrant - LANTERN HEALTH&BEAUTY LAB INC. (086860340)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Lantern Science Co.,Ltd.421222423manufacture(54860-383)
    Establishment
    NameAddressID/FEIBusiness Operations
    Greater Pacific Industries,Inc.962000253label(54860-383)
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