Label: SKIN LAUNDRY SUN DEFENSE MINERAL SPF 30 SUNSCREEN BROAD SPECTRUM SPF 30 UVA UVB- zinc oxide cream

  • NDC Code(s): 83727-295-00
  • Packager: Skin Laundry Holdings, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 6, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Drug Facts

  • Active ingredient

    Zinc Oxide 18.2%

    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 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 ● 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 skin ging. 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 ● Children under 6 months: Ask a  doctor

  • Inactive ingredients

    Water (Aqua), Caprylic/Capric Triglyceride, C13-15 Alkane, Pentylene Glycol, C15-19 Alkane, Propanediol, Bis-Diglyceryl Polyacyladipate-2, Gluconolactone, Polyacrylate Crosspolymer-6, Polyhydroxystearic Acid, Cetearyl Alcohol, Inositol, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Coco-Glucoside, Arachidyl Alcohol, Polyglycerin-3, Polyglyceryl-3 Lactate/Laurate, Sodium Benzoate, Tocopherol, Xanthan Gum, Bisabolol, Behenyl Alcohol, Sodium Citrate, Sodium Dilauramidoglutamide Lysine, Sclerotium Gum, Arachidyl Glucoside, Citric Acid, Physalis Alkekengi Calyx Extract, Sodium Phytate, Calcium Gluconate, Beta-Carotene

  • Other information

    Protect the product in this this container from excessive heat and direct sun

  • Question or comments?

    Product Questions, email Hello@skinlaundry.com You may report side effects to FDA at 1-800-FDA-1088

  • Package Labeling:

    Outer Package2Inner Package2

  • INGREDIENTS AND APPEARANCE
    SKIN LAUNDRY SUN DEFENSE MINERAL SPF 30 SUNSCREEN BROAD SPECTRUM SPF 30 UVA UVB 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83727-295
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION182 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALKEKENGI OFFICINARUM CALYX (UNII: AL7F9NO9HR)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    CALCIUM GLUCONATE (UNII: SQE6VB453K)  
    BETA CAROTENE (UNII: 01YAE03M7J)  
    POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)  
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    C13-15 ALKANE (UNII: 114P5I43UJ)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    C15-19 ALKANE (UNII: CI87N1IM01)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    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)  
    INOSITOL (UNII: 4L6452S749)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83727-295-001 in 1 CARTON10/14/2023
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/14/2023
    Labeler - Skin Laundry Holdings, Inc. (118584348)