Label: DOCTOR BABOR SOLAR DEFENSE MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- zinc oxide cream

  • NDC Code(s): 44924-902-01
  • Packager: BABOR Cosmetics America Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2024

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

  • Drug Facts

  • Active Ingredient

    Zinc Oxide 18.22%

  • 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 aging caused by the sun.
  • Warnings

    For external use only.

    Do not use

    on damaged or broken skin.

    When using the product

    keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor

    if rash occurs.

    Keep out of reach of children.

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

  • Directions

    • Apply generously 15 minutes before sun exposure as needed.
    • Reapply at least every 2 hours
    • Use a water-resistant sunscreen if swimming or sweating
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early 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 am to 2 pm
    • Wear longsleeved shirts, pants, hats, and sunglasses
    • Children under 6 months: Ask a doctor.
  • Inactive ingredients

    water/aqua/eau, caprylic/capric triglyceride, C13-15 Alkane, pentylene glycol, C15-19 Alkane, propanediol, bis-diglyceryl polyacyladipate-2, gluconolactone, polyhydroxystearic acid, polyacrylate crosspolymer-6, cetearyl alcohol, inositol, isostearic acid, lecithin, polyglyceryl-3 polyricinoleate, coco-glucoside, arachidyl alcohol, polyglycerin-3, polyglyceryl-3 lactate/laurate, sodium benzoate, tocopherol, bisabolol, xanthan gum, behenyl alcohol, sodium citrate, sodium dilauramidoglutamide lysine, sclerotium gum, arachidyl glucoside, citric acid, physalis alkakengi calyx extract, sodium phytate, t-butyl alcohol, calcium gluconate, glucose, beta-carotene.

  • Other Information

    Protect this product from excessive heat and direct sun

  • Questions or comments?

    You may report serious adverse evenst from the use of this product by calling toll free 1-800-333-4055

  • Company Information

    Made in the USA

    Manufactured for:

    BABOR Cosmetics America Corp.

    2980 NE 207th St, Ste 402 Aventura,

    FL 33180 www.babor.com

  • Product Packaging

    1

  • INGREDIENTS AND APPEARANCE
    DOCTOR BABOR SOLAR DEFENSE MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44924-902
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE182.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    INOSITOL (UNII: 4L6452S749)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    CALCIUM GLUCONATE (UNII: SQE6VB453K)  
    BETA CAROTENE (UNII: 01YAE03M7J)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    C15-19 ALKANE (UNII: CI87N1IM01)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    PHYSALIS ALKEKENGI CALYX (UNII: AL7F9NO9HR)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    C13-15 ALKANE (UNII: 114P5I43UJ)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44924-902-011 in 1 CARTON12/12/2024
    130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/12/2024
    Labeler - BABOR Cosmetics America Corp (139251763)