Label: CARPE SPF 30 FACE PRIMER- titanium dioxide, zinc oxide lotion

  • NDC Code(s): 83306-414-83
  • Packager: Clutch, Inc. DBA Carpe
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 20, 2024

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  • Active Ingredients

    Titanium Dioxide – 5.3%
    Zinc Oxide – 2.4%

  • 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 useon damaged or broken skin.
    • When using this productkeep out of eyes. Rinse with water to remove.
    • 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.
  • Directions

    • Apply liberally 15 minutes before sun exposure.

    • Reapply: • After 40 minutes of swimming or sweating. • Immediately after towel drying. • At least every 2 hours.

    • Children under six months: Ask a doctor.
    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.

  • Inactive Ingredients

    Aluminum Hydroxide, Cyclopentasiloxane, Dimethicone Crosspolymer, Helianthus Annuus (Sunflower) Extract, Hydrogen Dimethicone, Iron Oxides, Isopropyl Myristate, Isopropyl Titanium Triisostearate, Mica, Octyldodecyl Oleate, Oryza Sativa (Rice) Bran Extract, Polyamide-5, Polysilicone-11, Propylene Carbonate, Rosmarinus Officinalis (Rosemary) Leaf Extract, Silica Silylate, Stearalkonium Hectorite, Synthetic Wax, Tocopherol

  • Other Information

    Protect this product fro excessive heat and direct sun.

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    CARPE SPF 30 FACE PRIMER 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83306-414
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.3 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SYNTHETIC WAX (1900 MW) (UNII: 5M631N9V0S)  
    HYDROGEN DIMETHICONE (30 CST) (UNII: JF2ZJ6R2WD)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXYHYDROXIDE (UNII: 87PZU03K0K)  
    RICE BRAN (UNII: R60QEP13IC)  
    ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    POLYAMIDE-5 (UNII: UEM62QMW5F)  
    ROSEMARY (UNII: IJ67X351P9)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83306-414-8348 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/01/2023
    Labeler - Clutch, Inc. DBA Carpe (080214892)