GLYTONE SUNCARE SPF 50  - avobenzone, homosalate, octisalate and octocrylene spray 
Pierre Fabre Dermo Cosmetique

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                                             Purpose
Avobenzone 3%.............................................Sunscreen
Homosalate 10%............................................Sunscreen
Octisalate 5%.................................................Sunscreen
Octocrylene 5%..............................................Sunscreen

Sunscreen

Uses  - Sun protection factor 50  - Helps prevent sunburn caused by UVA/UVB exposure

Warnings  For external use only

Flammable: do not use neat heat, flame or while smoking. Avoid long term storage above 104 Degree F (40 Degree C). May stain some fabrics.

When using this product  - Keep out of eyes and eyelids.  - Do not spray directly on face. Spray onto hands and apply onto face, keeping away from eyes and eyelids.  - If contact with eyes occurs, rinse with water.  - Do not store at temperature above 120 Degree F. Do not puncture or incinerate. Contents under pressure.

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

Directions  - Apply generously and evenly onto body 30 minutes before sun exposure, and every two hours and after towel drying, swimming or perspiring.  - For face, spray onto hands and apply to face.  - For body, spray 4-6 inches from skin.  - For children less than six months of age, check with physician.

Inactive Ingredients
SD Alcohol 40-B, Butyloctyl Salicylate, Undecylcrylene Dimethicone, Acrylates/Octylacrylamide Copolymer, Phytic Acid, Tocopheryl Glucoside, Phyllanthus Emblica Fruit Extract, Ethylbisiminomethylguaiacol Manganese Chloride.

2371A  DOT-SP14724  M5867  3  64760 03055  5  Pierre Fabre  Distributed by:  Genesis Pharmaceutical, Inc.,  Parsippany, NJ 07054  www.glytone-usa.com  1-800-459-8663  Made in U.S.A.

GluTONE SUNCARE  block sunscreen spray mist SPF 50  DELTA-TOCOPHERYL G.C / Mn-PORPHYRIN ANTIOX-COMPLEX  - UVA/UVB PROTECTION  - ANTIOXIDANT PROTECTION  - FRAGRANCE FREE  - WATER RESISTANT  - PABA-FREE  - OIL-FREE  - NON-COMEDOGENIC  177 mL / 6 Fi. Oz.

Glytone


GLYTONE SUNCARE SPF 50 
avobenzone, homosalate, octisalate, octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67015-1200
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE3 mL  in 100 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE10 mL  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE5 mL  in 100 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLOCTYL SALICYLATE 
PHYTIC ACID 
PHYLLANTHUS EMBLICA FRUIT 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:67015-1200-01 BOTTLE ( BOTTLE) in 1 PACKAGEcontains a BOTTLE
1177 mL in 1 BOTTLEThis package is contained within the PACKAGE (67015-1200-0)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/09/2011

Labeler - Pierre Fabre Dermo Cosmetique (378028104)
Establishment
NameAddressID/FEIOperations
Formulated Solutions, LLC143266687manufacture

Revised: 06/2011 Pierre Fabre Dermo Cosmetique