CARPE SPF 30 FACE PRIMER- titanium dioxide, zinc oxide lotion 
Clutch, Inc. DBA Carpe

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.

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Carpe - Sweat Absorbing Lasting Matte SPF Primer (11-ER-077)

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.

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.

Label

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 finalM02005/01/2023
Labeler - Clutch, Inc. DBA Carpe (080214892)

Revised: 6/2023
Document Id: feac58ea-9bdf-243f-e053-6394a90a2831
Set id: feac5ee2-faa5-fd17-e053-6394a90a7f99
Version: 1
Effective Time: 20230621
 
Clutch, Inc. DBA Carpe