Label: OS-01 FACE SPF BS SPF 30 TINTED DEEP- zinc oxide cream

  • NDC Code(s): 84451-005-01, 84451-005-02
  • Packager: ONESKIN INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 19, 2025

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

  • ACTIVE INGREDIENT

    Active ingredients : Zinc Oxide 17.5%.

  • PURPOSE

    Purpose : Sunscreen

  • INDICATIONS & USAGE

    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

    Warnings

    For external use only.

  • DO NOT USE

    Do not use on damaged or broken skin.

  • WHEN USING

    When using this product keep out of eyes.

    Rinse with water to remove.

  • STOP USE

    Stop use and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions:

    Apply liberally 15 minutes before sun exposure.
    Reapply at least every 2 hours
    Use a water-resistant sunscreen If swimming or sweating.
    Children under 6 months of age: Ask a Doctor.
    Sun Probation Measures: 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 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

  • OTHER SAFETY INFORMATION

    Other information

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

  • INACTIVE INGREDIENT

    Inactive Ingredients
    Water (Aqua),Caprylic/Capric Triglyceride, Glycerin, Methyl Dihydroabietate, Cetearyl Alcohol, Cetyl Palmitate, Coco-Glucoside, Caprylyl/Capryl Glucoside, Sorbitan Palmitate, Sorbitan Olivate, Butyrospermum Parkii (Shea) Nut Extract, Ethyl Ferulate, Bisabolol, Allantoin, Hydrolyzed Jojoba Esters, Acacia Senegal Gum, Polyhydroxystearic acid, Polyglyceryl-3 Polyricinoleate, Isostearic acid, Lecithin, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Decapeptide-52*,Oryza Sativa (Rice) Starch, Camellia Sinensis Leaf Extract, Euterpe Oleracea Fruit Extract, Caesalpinia Spinosa Fruit Pod Extract, Helianthus Annuus (Sunflower) Sprout Extract, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Xanthan Gum, Sodium Phytate, Propylene Glycol, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate, Triethoxycaprylylsilane, Alumina, Magnesium Oxide, Iron Oxides (CI 77491, CI 77492, CI 77499)

  • PRINCIPAL DISPLAY PANEL

    OS-01 Face SPF BS SPF30 Tinted Deep

  • INGREDIENTS AND APPEARANCE
    OS-01 FACE SPF BS SPF 30 TINTED DEEP 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84451-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE17.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITAN PALMITATE (UNII: 77K6Z421KU)  
    SODIUM PHYTATE (UNII: 88496G1ERL)  
    BISABOLOL (UNII: 24WE03BX2T)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CETEARYL ALCOHOL (UNII: 2DMT128M1S)  
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
    CAPRYLYL/CAPRYL GLUCOSIDE (UNII: E00JL9G9K0)  
    ACACIA SENEGAL GUM (UNII: 5C5403N26O)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    CI 77499 (UNII: XM0M87F357)  
    WATER (UNII: 059QF0KO0R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    CI 77491 (UNII: 1K09F3G675)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    ETHYL FERULATE (UNII: 5B8915UELW)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    ORYZA SATIVA (RICE) STARCH (UNII: 4DGK8B7I3S)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CI 77492 (UNII: EX438O2MRT)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    SHEANUT (UNII: 84H6HBP32L)  
    CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALLANTOIN (UNII: 344S277G0Z)  
    HYDROLYZED JOJOBA ESTERS (UNII: UDR641JW8W)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    ACAI (UNII: 46AM2VJ0AW)  
    ALUMINA (UNII: LMI26O6933)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84451-005-021 in 1 CARTON05/12/2025
    1NDC:84451-005-0140 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/12/2025
    Labeler - ONESKIN INC. (088037418)