Label: MD ACNE OIL FREE SPF 30 SUNSCREEN- octinoxate, octisalate, avobenzone cream

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

Drug Label Information

Updated November 11, 2023

If you are a consumer or patient please visit this version.

  • DRUF FACTS:

  • Active Ingredient:

    Octinoxate 7.5.0%

    Octisalate 5.00%

    Avobenzone 3.00%

    Sunscreen

  • Use For:

    • Helps prevent sunburn.
    • If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging 
  • 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 physician

    If irritation or rash develops.

    Keep out of reach of children.

    If product is swallowed, get medical attention or contact poison control center immediately.

  • Directions:

    • Apply liberally 15-minutes before sun exposure.
    • Reapply:

    - At least every two-hours.

    - Immediately after swimming, sweating or towel drying.

    SUN PROTECTION MEASURES: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including:

    - Limit time in the sun, especially between 10 am and 2 pm.

    - Wear long sleeve shirts, pants, hats and sunglasses.

    - For children under 6-months, consult a physician.

  • Other Ingredients:

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Ascorbic Acid (Vitamin C), Camellia Sinensis (Green Tea) Extract, Capric/Caprylic Triglyceride, Carbomer, Cetyl Alcohol, Cetearyl Olivate, Cucumis Sativus (Cucumber) Extract, Dimethicone, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Phenoxyethanol, Polysorbate-20, Sorbitan Olivate, Styrene/Acrylates Copolymer, Tocopheryl Acetate (Vitamin E).EDTA, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol.

  • Other Information:

    • Protect this product from excessive heat and direct sunlight.
  • Package Labeling:

    Label3

  • INGREDIENTS AND APPEARANCE
    MD ACNE OIL FREE SPF 30 SUNSCREEN 
    octinoxate, octisalate, avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71804-232
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CUCUMBER (UNII: YY7C30VXJT)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LICORICE (UNII: 61ZBX54883)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CORN (UNII: 0N8672707O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71804-232-04120 mL in 1 TUBE; Type 0: Not a Combination Product06/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/01/2018
    Labeler - MD Algorithms Inc. (080479826)