BULLFROG QUIK- avobenzone and homosalate and octisalate and octocrylene and oxybenzone gel BULLFROG QUIK GEL SPORT- avobenzone and homosalate and octisalate and octocrylene and oxybenzone spray

BullFrog Quik Gel Sport by

Drug Labeling and Warnings

BullFrog Quik Gel Sport by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc., Chattem Plant 1. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

BullFrog® Quik Gel® 
SPF 50 with UV Extender®

Active Ingredients 

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

Oxybenzone 6%

Purpose

Sunscreens

Uses

• higher SPF gives more sunburn protection
  
• helps prevent sunburn

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

Flammable

• keep away from fire or flame

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally before sun exposure and as needed
  
• reapply after prolonged swimming, vigorous activity or towel drying
  
• children under 6 months: ask a doctor

Inactive Ingredients

acacia farnesiana flower extract, acrylates/octylacrylamide copolymer, aloe barbadensis leaf extract, camellia oleifera leaf extract, chamomilla recutita (matricaria) flower extract, cyclomethicone, ethylhexyl palmitate, fragrance, glycerin, hydroxypropyl cellulose, isopropyl myristate, lavandula angustifolia (lavender) extract, phenethyl benzoate, PPG-12/SMDI copolymer, propylene glycol, rosmarinus officinalis (rosemary) leaf extract, SD alcohol 40 (51% w/w), tocopheryl acetate (283-040) 

Dist. by Chattem, Inc. © 2009
P.O. Box 2219, Chattanooga, TN 37409 USA
0070038-01

BullFrog® Quik Gel® Sport Spray 
SPF 50 with UV Extender®

Active Ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

Oxybenzone 6%

Purpose

Sunscreens

Uses

• helps prevent sunburn 
  
• higher SPF gives more sunburn protection

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

Flammable

• keep away from fire or flame

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally before sun exposure and as needed
  
• reapply after prolonged swimming, vigorous activity or towel drying
  
• children under 6 months: ask a doctor

Inactive Ingredients

acacia farnesiana flower extract, acrylates/octylacrylamide copolymer, aloe barbadensis leaf extract, camellia oleifera leaf extract, chamomilla recutita (matricaria) flower extract, cyclomethicone, ethylhexyl palmitate, fragrance, glycerin, isopropyl myristate, lavandula angustifolia (lavender) extract, phenethyl benzoate, PPG-12/SMDI copolymer, propylene glycol, rosmarinus officinalis (rosemary) leaf extract, SD alcohol 40 (52% w/w), tocopheryl acetate (283-041)

Dist. by Chattem, Inc. © 2009
P.O. Box 2219
Chattanooga, TN 37409 USA
www.bullfrogsunblock.com
May stain some fabrics or plastics
0070056-02

Principal Display Panel

NEW!
Bull
Frog
SPF
50
Quik Gel® 
Sunblock
With
UV Extender®

• Dries Instantly
  
• UVA/UVB Protection
  
• Waterproof
  
• Sweatproof
  
• Non-greasy
  
• Oil-free, Won’t Clog Pores

5 FL OZ (147 ML)

Principal Display Panel

NEW!
Bull
Frog
SPF
50
Quik Gel®
SPORT SPRAY
Sunblock
With
UV Extender®

• Dries Instantly
  
• UVA/UVB Protection
  
• Waterproof
  
• Sweatproof
  
• Non greasy
  
• Oil-free, Won’t Clog Pores

SPRAYS UPSIDE DOWN
4.7 FL OZ (138 ML)

INGREDIENTS AND APPEARANCE

BULLFROG QUIK 
avobenzone and homosalate and octisalate and octocrylene and oxybenzone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-3305
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.03 g  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.15 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.05 g  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.1 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.06 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CHAMOMILE (UNII: FGL3685T2X)
CYCLOMETHICONE (UNII: NMQ347994Z)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LAVENDER EXTRACT (UNII: 19AH1RAF4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-3305-9	147 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2009

BULLFROG QUIK GEL SPORT 
avobenzone and homosalate and octisalate and octocrylene and oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-3318
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.03 g  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.15 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.05 g  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.1 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.06 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CHAMOMILE (UNII: FGL3685T2X)
CYCLOMETHICONE (UNII: NMQ347994Z)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LAVENDER EXTRACT (UNII: 19AH1RAF4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-3318-0	138 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2009

Labeler - Chattem, Inc. (003336013)

Establishment
Name	Address	ID/FEI	Business Operations
Chattem Plant 1		003336013	ANALYSIS, LABEL, MANUFACTURE, PACK, RECOVERY, RELABEL, REPACK