Label: TULIP DEW SUNSCREEN- zinc oxide lotion

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

Drug Label Information

Updated October 19, 2023

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

  • Drug Facts

  • Active Ingredient

    Zinc Oxide 12%

    Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn if used as directed with other sun protection measures (see ), decreases the risk of skin cancer & early skin aging caused by the sun. Directions
  • 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 & ask a doctor

    • if skin 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

    • REAPPLY : use a water-resistant sunscreen if swimming or sweating

    • at least every 2 hours

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

    • limit your time in the sun, especially from 10 a.m – 2 p.m.

    • wear long-sleeved shirts, pants, hats and sunglasses

    • Children under 6 months of age: ask a doctor.

    • Shake well

  • Other information

    • Protect the product in this container from excessive heat and direct sun.
  • Inactive Ingredients:

    Water (Aqua), C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Jojoba Esters, Tridecyl Salicylate, Propanediol, Polyglyceryl-4 Disostearate/Polyhydroxystearates/Sebacate, Niacinamide, Methylpropanediol, Silica, Nylon-12, Coco-Caprylate, Tulipa Gesneriana/Kaurmanniana Meristem Cell Lysate Filtrate Extract, Helianthus Annuus Extract, Glycerin, Sodium Hyaluronate, Sodium Lactate, Bisabolol, Allantoin, Oryza Sativa Bran Extract, Terminalia Ferdinandiana Fruit Extract, Podocarpus Elatus Fruit Extract, Pleiogynium Timoriense Fruit Extract, Lecithin, Hydrogenated Lecithin, Leuconostoc/Radish Root Ferment Filtrate, Rosmarinus Officinalis Leaf Extract, Sodium Chloride, Polyglyceryl-2 Dipolyhydroxystearate, Caprylyl Glycol, Methylheptyl Isostearate, Phenylpropanol, Tetrasodium Glutamate Diacetate, Sodium Gluconate, Pentylene Glycol, Sodium Hydroxide, Phenethyl Alcohol, Potassium Sorbate, Alcohol, Hamamelis Virginiana Water, Citric Acid, CI 77499, CI 77492, CI 77491.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    TULIP DEW SUNSCREEN 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82548-4530
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION120 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    NYLON-12 (UNII: 446U8J075B)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    ALLANTOIN (UNII: 344S277G0Z)  
    KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
    PODOCARPUS ELATUS FRUIT (UNII: R4N1M6CZCY)  
    PLEIOGYNIUM TIMORIENSE FRUIT (UNII: AF3VFG6MLV)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    ROSEMARY (UNII: IJ67X351P9)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    METHYLHEPTYL ISOSTEARATE (UNII: 981F40Q9FF)  
    PHENYLPROPANOL (UNII: 0F897O3O4M)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ALCOHOL (UNII: 3K9958V90M)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82548-4530-11 in 1 CARTON05/01/2022
    155 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 DrugM02005/01/2022
    Labeler - Bloomeffects, Inc. (096991853)