CREAM- zinc oxide, titanium dioxide cream 
Oxygen Development LLC

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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TARTE high-performance naturals BB tinted treatment primer Broad Spectrum SPF 30 Sunscreen

Active Ingredients

Titanium Dioxide 4.55%

Zinc Oxide 3.5%

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 aging caused by the sun.

Warnings

For external use only. Stop use and ask a doctor if rash occurs. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove.

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control center right away.

Directions

Shake before use. Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: Ask a doctor. Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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 sunlight.

You may report a serious adverse reaction to: tarte c/o Report Reaction, LLC, P.O. Box 22, Plainsboro, NJ 08536-0222

Inactive Ingredients

Cyclopentasiloxane, Isododecane, Polysilicone-11, Polymethylsilsesquioxane, Hexyl Laurate, PEG-10 Dimethicone, Polyglyceryl-4 Isostearate, Stearic Acid, Cetyl PEG/PPG-10/1 Dimethicone, Alumina, Dipalmitoyl Hydroxyproline, Triethoxycaprylylsilane,, Mica, Titanium dioxide (CI 77891), Iron oxides (CI 77491, CI 77492, CI 77499, OX100FP000371

Package Label

61354-084-01_aw61354-083-01_aw

CREAM 
zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61354-084
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.54 mg  in 100 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.49 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
ISODODECANE (UNII: A8289P68Y2) 10.69 mg  in 100 mg
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) 3.19 mg  in 100 mg
HEXYL LAURATE (UNII: 4CG9F9W01Q) 1.76 mg  in 100 mg
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) 55.74 mg  in 100 mg
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) 1.65 mg  in 100 mg
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) 1.5 mg  in 100 mg
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) 4.68 mg  in 100 mg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61354-084-011 in 1 CARTON08/30/2022
1100 mg in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02008/30/2022
Labeler - Oxygen Development LLC (137098492)
Establishment
NameAddressID/FEIBusiness Operations
Oxygen Development LLC137098492manufacture(61354-084)

Revised: 8/2022
Document Id: e7763ac1-d05c-7f8f-e053-2995a90a6c15
Set id: e7760899-8b4a-9a2a-e053-2995a90a2fd5
Version: 1
Effective Time: 20220830
 
Oxygen Development LLC