ANHYDROUS SPF 30- titanium dioxide, zinc oxide cream 
Owen Biosciences, Inc.

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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Owen Biosciences Anhydrous SPF 30 30 g tube

Drug Facts

Active ingredients                  Purpose

Titanium Dioxide 10.20%        Sunscreen

Zinc Oxide 3.70%                  Sunscreen

USES

Helps Prevent sunburn.

Higher SPF gives more sunburn protection

Provides moderate protection against sunburn.

Warnings

For external use only. When using this product

keep out of eyes.  Rinse with water to remove.

Stop use and ask doctor if rash and irritation

develops and lasts.  Keep out of reach of

children. If swallowed, get medical help or

contact poison control center right away.

Directions

Apply evenly before sun exposure and as

needed.  For children under 6 months of age: ask

a doctor.  Reapply as needed or after towel

drying, swimming or perspiring.

Other Information

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and other

harmful effects of the sun.

Inactive Ingredients

Cyclopentasiloxane, Cyclomethicone, Dimethicone Crosspolymer, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer,

Dimethicone/Vinyl Dimethicone Crosspolymer, Melanin, Tribehenin, Calcium Behenate, Sorbitan Isostearate, Dimethiconol,

Alumina, PEG-10 Dimethicone, Methicone, Iron Oxides.

main label

ANHYDROUS SPF 30 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59958-200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE10.2 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.7 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE (UNII: NMQ347994Z) 17.5 g  in 100 g
TRIBEHENIN (UNII: 8OC9U7TQZ0) 1 g  in 100 g
FERRIC OXIDE RED (UNII: 1K09F3G675) 0.09 g  in 100 g
FERRIC OXIDE YELLOW (UNII: EX438O2MRT) 0.25 g  in 100 g
FERROSOFERRIC OXIDE (UNII: XM0M87F357) 0.01 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59958-200-0330 g in 1 TUBE; Type 0: Not a Combination Product01/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/2011
Labeler - Owen Biosciences, Inc. (790003045)
Registrant - Owen Biosciences, Inc. (790003045)
Establishment
NameAddressID/FEIBusiness Operations
Owen Biosciences, Inc.790003045manufacture(59958-200)

Revised: 4/2022
Document Id: dd451187-2dbd-783d-e053-2995a90ab7c8
Set id: 1510cae2-9c8f-45ba-b088-67747af3d30c
Version: 2
Effective Time: 20220422
 
Owen Biosciences, Inc.