CREAM OIL SUNSCREEN- zinc oxide, titanium dioxide sunscreen 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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Cream Oil Sunscreen

Active Ingredients Purpose

Zinc Oxide 21.50%...... Sunscreen

Titanium Dioxide 1.25%...... Sunscreen

Uses

Helps protect against sunburn
provides moderate protection against sunburn

Warnings

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove

Stop use and ask doctor if rash occurs

Keep out of reach of children If swallowed, get medicl help or contact poison control center.

Directions

Apply generously and evenly 15 minutes before sun exposure.
Children under 6 months of age: ask 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 10a.m. - 2p.m.
wear long sleeve shirts, pants, hats and sunglasses.
Reapply at least every 2 hours
Use a water-resistant sunscreen if swimming or sweating

Other Information

Protect the product in this contianer from heat and direct sun.

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CREAM OIL SUNSCREEN 
zinc oxide, titanium dioxide sunscreen cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59958-408
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE21 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 32.6 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59958-408-021 in 1 CARTON04/04/2020
1NDC:59958-408-0150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/04/2020
Labeler - Owen Biosciences, Inc. (790003045)
Establishment
NameAddressID/FEIBusiness Operations
Owen Biosciences, Inc.790003045manufacture(59958-408)

Revised: 1/2023
Document Id: f2684b4f-05d1-604c-e053-2a95a90afca5
Set id: b2ccdfea-1c27-42af-b9d8-752e9f91ae87
Version: 3
Effective Time: 20230116
 
Owen Biosciences, Inc.