Label: CAY SKIN ISLE LIP BALM SPF 30- avobenzone, homosalate, octisalate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 21, 2023

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  • Drug Facts

  • Active ingredients (w/w)

    Avobenzone 3%, Homosalate 10%, Octisalate 5%

  • 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

    on damaged or broken skin.

    When using this product

    keep out of eyes. Rinse with water to remove.

    Stop use and consult a doctor

    if skin rash occurs.

    Keep out of reach of children.

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

  • Directions

    • Adults and children over 6 months of age:
    • Apply liberally 15 minutes before sun exposure.
    • Reapply: at least every 2 hours or after 40 minutes of swimming or sweating.
    • Children under 6 months of age: ask a doctor.
    • 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. - 2 p.m.; wear long-sleeved shirts, pants, hats and sunglasses.
  • Other information

    Protect this product from excessive heat and direct sun.

  • Inactive ingredients

    Hydrogenated Polyisobutene, C18-38 Alkyl Hydroxystearoyl Stearate, Butyrospermum Parkii (Shea) Oil, Butyloctyl Salicylate, VP/Hexadecene Copolymer, Ozokerite, Cetyl Alcohol, Vanillin, Glyceryl Stearate, Phytosteryl/Octyldodecyl Lauroyl Glutamate, Methyl Dihydroabietate, Trihydroxystearin, Erythritol, Aloe Barbadensis Leaf Juice, Water (Aqua), Chondrus Crispus Extract

  • Questions or comments?

    cayskin.com (256) 396-8268

  • Product Packaging

    isle lip balm

  • INGREDIENTS AND APPEARANCE
    CAY SKIN ISLE LIP BALM SPF 30 
    avobenzone, homosalate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82657-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    SHEANUT OIL (UNII: O88E196QRF)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ERYTHRITOL (UNII: RA96B954X6)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CERESIN (UNII: Q1LS2UJO3A)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)  
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    WATER (UNII: 059QF0KO0R)  
    C18-38 ALKYL HYDROXYSTEAROYL STEARATE (UNII: WW4FVB2PEM)  
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    VANILLIN (UNII: CHI530446X)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82657-001-011 in 1 CARTON03/29/2022
    110 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/29/2022
    Labeler - Cay Skin, Inc. (118574309)
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