POWDER- titanium dioxide powder 
Oxygen Development LLC

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PUR 4-in-1 Pressed Mineral Makeup - LINEN MN3

Active Ingredient

Titanium Dioxide

Purpose

Sunscreen

Uses

Helps prevent sunburn.

Warnings

For external use only

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 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 • Use a water resistant sunscreen if swimming or sweating • Reapply at least every 2 hours • Children under 6 months: ask a doctor

Other Information

Protect this product from excessive heat and direct sun • In the unlikely event of an adverse reaction, please contact 1.866.PUR.0022.

Inactive Ingredient

Mica, Caprylic/Capric Triglyceride, Boron Nitride, Bismuth Oxychloride, Zinc Stearate, Magnesium Silicate, Sodium Starch Octenylsuccinate, Mannitol, Sodium Gluconate, Citric Acid, Sodium Citrate, Waltheria Indica Leaf Extract, Dextrin, Ferulic Acid, Lactic Acid (L), Butyrospermum Parkii (Shea) Butter, Retinol, Ceramide AP, Silica, Tocopheryl Acetate, Aqua, Glucosamine HCI, Pisum Sativum (Pea) Extract, Bambusa Vulgaris Leaf/Stem Extract, Magnesium Carbonate, Iron Oxides (CI 77491, CI 77492, CI 77499), May Contain: Titanium Dioxide (CI 77891), Ultramarines (CI 77007).

Package label - Principal display panel

61354-117-01-aw61354-117-02_aw61354-117-01_aw

POWDER 
titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61354-117
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED1.75 mg  in 100 mg
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE10 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 8 mg  in 100 mg
MAGNESIUM SILICATE (UNII: 9B9691B2N9) 2 mg  in 100 mg
MANNITOL (UNII: 3OWL53L36A) 1.67 mg  in 100 mg
BORON NITRIDE (UNII: 2U4T60A6YD) 8 mg  in 100 mg
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 0.5 mg  in 100 mg
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) 1.89 mg  in 100 mg
MICA (UNII: V8A1AW0880) 51.05 mg  in 100 mg
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) 10 mg  in 100 mg
ZINC STEARATE (UNII: H92E6QA4FV) 2.8 mg  in 100 mg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61354-117-021 in 1 CARTON10/27/2023
1NDC:61354-117-01100 mg in 1 CUP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02010/27/2023
Labeler - Oxygen Development LLC (137098492)
Establishment
NameAddressID/FEIBusiness Operations
Oxygen Development LLC137098492manufacture(61354-117)

Revised: 10/2023
Document Id: 08b52f29-c1a1-c673-e063-6294a90a9a7a
Set id: 08b52f29-c1a0-c673-e063-6294a90a9a7a
Version: 1
Effective Time: 20231027
 
Oxygen Development LLC