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Name:Avobenzone, Octinoxate, Titanium Dioxide
Manufacturer:Grafton Products Corp.
Category:Over-the-counter (OTC) Marketed Drugs


AVOBENZONE, OCTINOXATE, TITANIUM DIOXIDE  - avobenzone, octinoxate and titanium dioxide lipstick 
GRAFTON PRODUCTS CORP.

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 Ingredients

Avobenzone 1.50% (w/w)
Octinoxate 6.00% (w/w)
Titanium Dioxide 1.29% (w/w)

Purpose

Sunscreen

Use

  • Helps prevent sunburn
  • Provides moderate protection against sunburn

Warnings

  • Stop use if rash occurs

Directions

  • Apply liberally before sun exposure and as needed.
  • Children under six months of age: ask a doctor.

Inactive ingredients

Hydrogenated polyisobutene, Microcrystalline wax, Caprylic/Capric Triglyceride, Tridecyl Trimellitate, Polybutene, Polyethylene, Ricinus Communis oil (castor) seed oil, Diisostearyl Malate, Butyrospermum Parkii (shea butter), Ethylhexyl palmitate,Oryzanol, Tocopheryl acetate,Tribehenin, Prunus armeniaca (apricot)  kernel oil, Dimethicone, Cyclomethicone, Sorbitan isostearate, Ethylene/VA Copolymer, Isododecane, BHT, Lactic acid, Palmitoyl Oligopeptide, Propylparaben, Methylparaben, Flavor, Iron oxide*, Mica*, Red 7 Lake*, Titanium dioxide*

* Contain one or more of these ingredients.

Questions and comments?

Call 800-662-5387 M-F 9.00 - 5.00 est

Principal Display Panel

Forme®

DELICIOUS LIP BALM

- Vanilla -

Sunscreen SPF 12      NET WT. 0.11 OZ (3.2g)

Do not use if the seal is missing

Made In Italy

Distributed by:-  Grafton Products Corp., 3600
S. Congress Ave Suite C, Boynton Beach, FL 33426

Forme® is a registered trademark of Grafton Products Corp.Forme Delicious Lip Balm SPF 12-3.2g-Primary Package Label


AVOBENZONE, OCTINOXATE, TITANIUM DIOXIDE 
avobenzone, octinoxate, titanium dioxide lipstick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52094-070
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 0.048 g  in 3.2 g
OCTINOXATE (OCTINOXATE) OCTINOXATE 0.192 g  in 3.2 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 0.041 g  in 3.2 g
Inactive Ingredients
Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES  
CASTOR OIL  
SHEA BUTTER  
ETHYLHEXYL PALMITATE  
.ALPHA.-TOCOPHEROL ACETATE, DL-  
TRIBEHENIN  
DIMETHICONE  
CYCLOMETHICONE  
BUTYLATED HYDROXYTOLUENE  
LACTIC ACID  
PROPYLPARABEN  
METHYLPARABEN  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52094-070-01 3.2 g in 1 CONTAINER None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 03/29/2010

Labeler - GRAFTON PRODUCTS CORP. (009705039)
Registrant - CHROMAVIS SPA (338561621)
Establishment
Name Address ID/FEI Operations
CHROMAVIS SPA 338561621 manufacture

Revised: 03/2010 GRAFTON PRODUCTS CORP.



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


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