Label: LUXURY SUN RITUAL PORE SMOOTHING SPF 30 SUNSCREEN- zinc oxide lotion

  • NDC Code(s): 82404-101-11, 82404-101-12, 82404-101-13, 82404-101-14, view more
    82404-101-15
  • Packager: JANE STREET LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 5, 2023

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  • ACTIVE INGREDIENT

    ZINC OXIDE 10%

  • PURPOSE

    SUNSCREEN

  • USE

    HELPS PREVENT SUNBURN

  • 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 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.
    • USE A WATER-RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.
    • REAPPLY AT LEAST EVERY 2 HOURS.
    • SUN PROTECTION 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 INFORMATION

    • PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.
  • INACTIVE INGREDIENTS

    Water, Butylene Glycol, Caprylic/Capric Triglyceride, Dimethicone, Cetearyl Alcohol, Cetearyl Olivate, Polyglyceryl-3 Diisostearate, Sorbitan Olivate, Jasminum Officinale (Jasmine) Extract, Hibiscus Sabdariffa Flower Extract, Adenium Obesum (Desert Rose) Extract, Cetearyl Glucoside, Triethoxycaprylylsilane, Camellia Sinensis (Green Tea) Leaf Oil, Tocopheryl Acetate, Xanthan Gum, Phenoxyethanol, Ethylhexylglycerin, Iron Oxides.

  • PRINCIPAL DISPLAY PANEL

    SJ LUXURY SUN RITUAL

  • INGREDIENTS AND APPEARANCE
    LUXURY SUN RITUAL  PORE SMOOTHING SPF 30 SUNSCREEN
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82404-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
    HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)  
    ADENIUM OBESUM WHOLE (UNII: SH5EDD5OZA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82404-101-121 in 1 BOX05/01/2022
    1NDC:82404-101-1150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:82404-101-133 mL in 1 TUBE; Type 0: Not a Combination Product05/01/2022
    3NDC:82404-101-151 in 1 BOX12/01/2022
    3NDC:82404-101-1425 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/01/2022
    Labeler - JANE STREET LLC (081575951)
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