Label: SHINE ON LIP SUNSCREEN BROAD SPECTRUM SPF 50- avobenzone, homosalate, octinoxate, octisalate 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 November 12, 2020

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  • ACTIVE INGREDIENT

    Active Ingredients             Purpose

    Avobenzone 3% ............. Sunscreen

    Homosalate 10% ............ Sunscreen

    Octinoxate 7.5% ............ Sunscreen

    Octisalate 5% ................ Sunscreen

  • PURPOSE

    Uses

    • Helps prevent and tempararily protect chafed, chapped, cracked, or windburned skin and/or lips
    • 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
  • KEEP OUT OF REACH OF CHILDREN

    Children under 6 months: Ask a doctor

  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs

  • WARNINGS

    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
  • DOSAGE & ADMINISTRATION

    Directions

    • Apply liberally 15 minuts before sun exposure
    • Reapply after 80 minuts of swimming or sweating
    • Immediately after towel drying
    • At least every two hours

    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 10a.m. - 2p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Hydrogenated Polyisobutene, Butyloctyl Salicylate, Polyester-7, Diisopropyl Sebacte, Isodecyl Neopentanoate, Lauryl Lactate, Neopentyl Glycol Diheptanoate, Polyester-8, Tibehenin, Phenoxyethanol, Trihydroxystearin, Menthone Glycerin Acetal, Diethylhexy Syringylidenemalonate, Polybutene, Tocopheryl Acetate, Polysilicone-15, Octyldodecanol, Elaeis Guineensis (Palm) Oil, Benzoic Acid, Tocotrienols, Helianthus Annuus (Sunflower) Seed Oil, Dehydroacetic Acid, Tocopherol, Caprylic/Capric Triglyceride, BHT, Vits Vinifera (Grape) Seed Extract, Laminaria Ochroleuca Extract 

  • PRINCIPAL DISPLAY PANEL

    Shine-On!

    Lip Screen

    With Grape Polyphenols

    Broa Spectrum SPF 50

    Supergoop!

    Water resistant

    (80 minutes)

    0.14 fl. oz. / 4 ml.

    image description

  • INGREDIENTS AND APPEARANCE
    SHINE ON LIP SUNSCREEN   BROAD SPECTRUM SPF 50
    avobenzone, homosalate, octinoxate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-141
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    POLYESTER-7 (UNII: 0841698D2F)  
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    LAURYL LACTATE (UNII: G5SU0BFK7O)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    MENTHONE 1,2-GLYCEROL KETAL, (+/-)- (UNII: 7QQ1EE6RCP)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    POLYSILICONE-15 (UNII: F8DRP5BB29)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PALM OIL (UNII: 5QUO05548Z)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    TOCOTRIENOLS (UNII: KP2MW85SSQ)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    LAMINARIA OCHROLEUCA (UNII: 4R2124HE76)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-141-021 in 1 BOX01/05/2016
    1NDC:75936-141-014 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:75936-141-031.5 mL in 1 TUBE; Type 0: Not a Combination Product07/19/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/05/2016
    Labeler - TAYLOR JAMES, LTD. (033381850)
    Registrant - TAYLOR JAMES, LTD. (033381850)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosway Company Inc.052400223manufacture(75936-141)
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