Label: BEAUTY COUNTER DEW SKIN MOISTURIZER MEDIUM SPF 20- zinc oxide lotion

  • NDC Code(s): 69026-281-01, 69026-281-02
  • Packager: Beauty Counter, LCC
  • 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 3, 2022

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

  • Active Ingredients

    Zinc Oxide - 14%

    Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
    • if used as directed witho other sun production 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 aks a doctor

    if rash occurs

    Keep out of reach of children.

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

  • Directions

    • Apply liberally 15 minutes before sun exposure
    • Children under 6 months of age: Ask a doctor.
    • Sun Protection Measures

    Spending time in the sun increases you risk of skin cancer and early skin aging.  To decrease this risk, regularly  use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including:

    • Limit time in the sun, especially from 10AM-2PM
    • Wear long sleeved shirts, pants, hats and sunglasses
    • Reapply at leat every 2 hours
    • Use a water resistant sunscreen if swimming or sweating.
  • Other Information

    • Store at temperatures below 90°F.
    • Protect this product from excessive heat and direct sun.
  • Inactive Ingredients:

    Water, Caprylic/Capric Triglyceride, Coc-Caprylate, Trimethylsiloxysilicate, Isoprpyl Palmitate, Dimethicone/Vinyl Dimethicone Crosspolymer, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Ethylhexyl Palmitate, Isoproyl Myristate, Octyldodecyl Oleate, Dimethicone, Magnesium Sulfate, Beeswax, Glucolactone, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Lecithin, Sodium Hyaluronate, Sodium Chloride, Glycerin, Propanediol, Sodium Benzoate, Isoeicosane, Hydrogenated Castor Oil, Tetrahexyldecyl Ascorbate, Ribes Nigrum (Black Currant) Seed Oil, Octyldodecanol, Octyldodecyl Stearoyl Stearate,  Alcohol, Paeonia Suffruticosa (Peony) Root Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Solidago Virgqurea (Goldenrod) Extract, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Citrus Aurantium Dulcis (Orange) Oil, Rosa Damascena (Rose) Flower Oil, Salvia Sclarea (Clary) Oil, Citrus Aurantium Dulcis (Orange) Flower Oil, Vanilla Planifolia Fruit Extract, Silica, Titanium Dioxide, Iron Oxides, Mica.

  • PRINCIPAL DISPLAY PANEL

    Dew Skin carton

  • INGREDIENTS AND APPEARANCE
    BEAUTY COUNTER DEW SKIN MOISTURIZER MEDIUM   SPF 20
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69026-281
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION14 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    CITRUS SINENSIS FLOWER OIL (UNII: AJ56JP5TFP)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    ISOEICOSANE (UNII: AR294KAG3T)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)  
    OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)  
    PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    RIBES NIGRUM SEED OIL (UNII: GKE1188837)  
    ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)  
    ROSEMARY (UNII: IJ67X351P9)  
    CLARY SAGE OIL (UNII: 87L0D4U3M0)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
    VANILLA (UNII: Q74T35078H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69026-281-021 in 1 CARTON04/01/2015
    1NDC:69026-281-0140 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/01/2015
    Labeler - Beauty Counter, LCC (070346240)