Label: SKIN MD- octinoxate, octisalate, homosalate lotion

  • NDC Code(s): 44099-011-01, 44099-011-02, 44099-011-03, 44099-011-04, view more
    44099-011-05
  • Packager: 21st Century Formulations
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 24, 2023

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  • Active ingredients

    Octinoxate 7%

    Octisalate 5%

    Homosalate 3%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn.
    • Decreases the risk of skin cancer and early aging caused by the sun.
  • Warnings

    For external use only.

  • Do not use

    on damaged or broken skin

  • Stop use and ask a Doctor

    if rash occurs.

  • When using this product

    keep out of eyes. Rinse with water to remove.

  • 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.
    • Reapply at least every 2 hours.

      Spending time in the sun increases your risk of skin cancer and early skin aging.

  • Other information

    • Protect this product from excessive heat and direct sun.
  • Inactive ingredients

    Water (aqua), Aloe Barbadensis Leaf Extract (Aloe Vera), Cyclopentasiloxane, Dimethicone, Methyl Gluceth-20, Extracts of Arnica Montana Flower (Arnica), Symphytum Officinale Leaf (Camfrey), Chamomilla Recutita (Matricaria Chamomile), Achillea Millefolium (Yarrow), Chondrus Crispus (Carrageenan), Tocopheryl Acetate (Vitamin E), Sorbitan Oleate, 1,2 Hexanediol, Caprylyl Gylcol, Butylene Glycol, Aminomethyl Propanol, Phenoxyethanol (preservative), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Bis-Hydroxyethoxypropyl Dimethicone.

  • Questions?

    Call toll free 1-800-540-4790

    ®2013 Made in USA

    21st Century Formulations

    Beverly Hills, CA 90210

    www.skinmdnatural.com

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Skin MD_Shielding Lotion_SPF15_4oz

  • INGREDIENTS AND APPEARANCE
    SKIN MD 
    octinoxate, octisalate, homosalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44099-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 mg  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE3 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    COMFREY LEAF (UNII: DG4F8T839X)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST) (UNII: 7K226YI89Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44099-011-01117 mL in 1 BOTTLE; Type 0: Not a Combination Product08/19/2008
    2NDC:44099-011-02236 mL in 1 BOTTLE; Type 0: Not a Combination Product08/19/2008
    3NDC:44099-011-033785 mL in 1 BOTTLE; Type 0: Not a Combination Product08/19/2008
    4NDC:44099-011-04100 mL in 1 TUBE; Type 0: Not a Combination Product07/16/2018
    5NDC:44099-011-05200 mL in 1 TUBE; Type 0: Not a Combination Product07/16/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02008/19/2008
    Labeler - 21st Century Formulations (039644618)
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