CREAM- titanium dioxide, zinc oxide lotion 
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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BB TINTED TREATMENT PRIMER BROAD SPECTRUM SPF 30 SUNSCREEN. LIGHT 12-HOUR PRIMER

Active Ingredients

Titanium Dioxide 4.55%

Zinc Oxide 3.5%

Purpose

Sunscreen

Uses

Warnings

For external use only

Stop use and ask 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

Limit time in the sun, especially from 10 a.m.- 2p.m.
Wear long-sleeved shirts, pants, hats and sunglasses.

Other information

Inactive Ingredients

Cyclopentasiloxane, Isododecane, Polysilicone-11, Mica, Polymethylsilsesquioxane, Hexyl Laurate, PEG-10 Dimethicone, Polyglyceryl-4 Isostearate, Stearic Acid, Cetyl PEG/PPG-10/1 Dimethicone, Alumina, Triethoxycaprylylsilane, Dipalmitoyl Hydroxyproline, Diamond Powder, Iron Oxides.

Primary Package (Inner)

61354-051-35_AW

61354-051-35_AW

15 ML 61354-051-35

Secondary Package (Outer)

15 ml 61354-051-30 61354-051-35_AW

CREAM 
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61354-051
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.5 mg  in 100 mg
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.55 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
ISODODECANE (UNII: A8289P68Y2)  
MICA (UNII: V8A1AW0880)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61354-051-351 in 1 CARTON02/26/2021
115 mg in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/26/2021
Labeler - OXYGEN DEVELOPMENT, LLC (137098492)
Establishment
NameAddressID/FEIBusiness Operations
OXYGEN DEVELOPMENT, LLC137098492manufacture(61354-051)

Revised: 2/2023
Document Id: f45cfb71-4323-ac58-e053-2995a90a3d9e
Set id: bc3f0e8a-7746-7a66-e053-2a95a90a329b
Version: 2
Effective Time: 20230210
 
OXYGEN DEVELOPMENT, LLC