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Name:Alba Sunblock Facial Spf 20
Manufacturer:The Hain Celestial Group, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

ALBA SUNBLOCK FACIAL SPF 20  - zinc oxide and 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 INGREDIENTS

Zinc Oxide  8.0%

Titanium Dioxide  1.0%

              USES

  • Helps prevent sunburns
  • Higher SPF gives more sunburn protection
  • Apply liberally before sun exposure as needed
  • Reapply as needed or after swimming, perspiring or towel drying
  • Children under 6 months of age: ask doctor

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 Poison Control Center right away.

QUESTIONS?

Call (888) 659-7730 or visit www.AlbaBotanica.com

100% Vegetarian Ingredients

No Animal Testing

Alba Botanica

The Hain Celestial Group, Inc.

Melville, NY 11747

Made in the U.S.A.


image of tube label

ALBA SUNBLOCK FACIAL SPF 20 
zinc oxide, titanium dioxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-2387
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Zinc Oxide (Zinc Cation) Zinc Oxide 8.0 g  in 100 g
Titanium Dioxide (Titanium Dioxide) Titanium Dioxide 1.0 g  in 100 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61995-2387-4 113 g in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 10/28/2009

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

Revised: 06/2010 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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