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
- Marketing Status: OTC monograph 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 June 21, 2023
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- Active Ingredients
- Purpose
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CARPE SPF 30 FACE PRIMER
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83306-414 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 5.3 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 2.4 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:83306-414-83 48 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 05/01/2023 Labeler - Clutch, Inc. DBA Carpe (080214892)
