CATRIN DIAMOND MINERAL FOUNDATION- titanium dioxide, zinc oxide powder
Nature&Bio Co., Ltd.

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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ACTIVE INGREDIENT

Active ingredients: Titanium Dioxide 15.4%, Zinc Oxide 13%

INACTIVE INGREDIENT

Inactive ingredients: Mica, Bismuth Oxychloride, CI 77492, CI 77491, CI 77499, Quartz, Sapphire Powder, Diamond powder

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:

For external use only. When using this product: Keep out of eyes, Rinse with water to remove. Stop use and ask a doctor if: Rash or irritation develops and lasts, Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Indications and usage: Helps prevent sunburn, Higher SPF gives moresunburn protection.

DOSAGE & ADMINISTRATION

Dosage and administration: Apply evenly before sun exposure as needed.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

CATRIN DIAMOND MINERAL FOUNDATION
titanium dioxide, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69058-010
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.38 g in 9 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	1.17 g in 9 g

Ingredient Name	Strength
Inactive Ingredients
Mica (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69058-010-01	9 g in 1 CARTON

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	09/01/2014

Labeler - Nature&Bio Co., Ltd. (690332858)

Registrant - Nature&Bio Co., Ltd. (690332858)

Name	Address	ID/FEI	Business Operations
Establishment
Nature&Bio Co., Ltd.		690332858	manufacture(69058-010)