Drug Facts

AV3712501 MINERAL SUNSCREEN SPF 18 - titanium dioxide cream
The Hain Celestial Group, 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.

----------

Drug Facts

ACTIVE INGREDIENT

Titanium Dioxide 7.0%

USAGE

Helps prevent sunburn
Apply liberally at least 20 minutes prior to sun exposure
Reapply as needed
For children under the age of 6 months please contact physician before use

WARNINGS and PRECAUTIONS

For external use only.

When using this product avoid contact with eyes. If contact occurs, rinse throughly with water to remove.

Stop use and consult a physician if rash or irritation develops and lasts.

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center immediately.

QUESTIONS?

1-800-227-5120 or www.AvalonOrganics.com

image of bottle label

AV3712501 MINERAL SUNSCREEN SPF 18
titanium dioxide cream

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:61995-1125
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	7.0 g in 100 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61995-1125-3	99 g in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/01/2006

Labeler - The Hain Celestial Group, Inc. (858894996)

Name	Address	ID/FEI	Business Operations
Establishment
The Hain Celestial Group, Inc.		858894996	manufacture