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Name:Av3712501 Mineral Sunscreen Spf 18
Manufacturer:The Hain Celestial Group, Inc.
Category:Prescription Marketed Drugs


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.

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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 DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Titanium Dioxide (Titanium Dioxide) Titanium Dioxide 7.0 g  in 100 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61995-1125-3 99 g in 1 BOTTLE None

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

Labeler - The Hain Celestial Group, Inc. (858894996)
Establishment
Name Address ID/FEI Operations
The Hain Celestial Group, Inc. 858894996 manufacture

Revised: 03/2011 The Hain Celestial Group, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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