POWDER- zinc oxide, titanium dioxide powder 
Oxygen development

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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Tarteguard Mineral Powder sunscreen Broad Spectrum SPF 30

Active ingredients

Titanium Dioxide 8.6

zinc Oxide 10.0

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 again caused by the sun.

Warnings

For external use only

Stop Use

Stop use and ask doctor if rash occurs

Do not use

Do not use on damaged or broken skin

When using

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 rigth away

Directions

Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. reapply at lease every 2 hours. Children under 6 months: ask a doctor. optional: apply toall skin exposed to the sun. Sun Protection measures. spending time in the sin increases your risk ofg skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m-2p.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, New Jersey 08536-0222.

Primary package

61354-052_AW61354-052_AW61354-052_AW

Secondary Package

61354-052-01_AW

POWDER 
zinc oxide, titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61354-052
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE8.6 mg  in 100 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
JOJOBA OIL (UNII: 724GKU717M)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61354-052-011 in 1 CARTON02/23/2021
18 mg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/22/2021
Labeler - Oxygen development (137098492)
Establishment
NameAddressID/FEIBusiness Operations
Oxygen Development137098492manufacture(61354-052)

Revised: 2/2023
Document Id: f45d2f79-ec62-9e7f-e053-2995a90a48fa
Set id: bbf3e14d-84f3-fe4b-e053-2a95a90a1acc
Version: 2
Effective Time: 20230210
 
Oxygen development