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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Glytone Suncare SPF 50

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

Sunscreen


Use
Helps prevent sunburn
If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancr and early skin aging caused by the sun.

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  -

For sunscreen use

Apply to all skin exposed to the sun

Apply liberally and evenly 15 minutes before sun exposure

Reapply:

after 80 minutes of swming or sweating, immediately after towel drying, at least every 2 hours.

Sun Protection Measures, Spending time  in the sun increases your risk of skin cancer and early skin aging. To decrease this risk,, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 am - 2 pm, wear long-sleeve shirts, pants, hats and sunglasses

Children under 6 months: Ask a doctor

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.

GLYTONE SUNCARE  block

BROAD SPECTRUM SPF 50+ WATER RESISTANT (80 MINUTES)

spray mist sunscreen

  DELTA-TOCOPHERYL G.C / Mn-PORPHYRIN ANTIOX-COMPLEX  - UVA/UVB PROTECTION  - ANTIOXIDANT PROTECTION  - FRAGRANCE FREE  -  PABA-FREE  - OIL-FREE  - NON-COMEDOGENIC  MAXIMUM WATER RESISTANCE PER FDA SUNSCREEN REGULATION 177 mL / 6 Fi. Oz.

Glytone

GLYTONE SUNCARE SPF 50  
avobenzone, homosalate, octisalate, octocrylene spray
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67015-1200-01 in 1 PACKAGE
1177 mL in 1 BOTTLE
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/FEIBusiness Operations
Formulated Solutions, LLC143266687manufacture

Revised: 5/2012
 
Pierre Fabre Dermo Cosmetique