Label: DOCTOR BABOR PROTECT RX MINERAL SUNSCREEN SPF 30- zinc oxide cream

  • NDC Code(s): 44924-901-01
  • Packager: BABOR Cosmetics America Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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, 2021

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  • 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

    • reapply 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 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 event from the use of this product.

    Call 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

    protect rx

  • INGREDIENTS AND APPEARANCE
    DOCTOR BABOR PROTECT RX MINERAL SUNSCREEN SPF 30 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44924-901
    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
    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)  
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    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)  
    POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
    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:44924-901-011 in 1 CARTON02/01/2022
    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 not finalpart35202/01/2022
    Labeler - BABOR Cosmetics America Corp (139251763)
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