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Name:Bullfrog Ultimate Sheer Protection Face
Manufacturer:Chattem, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


BullFrog Ultimate Sheer Protection

BULLFROG ULTIMATE SHEER PROTECTION FACE - avobenzone, homosalate, octisalate and octocrylene lotion 
Chattem, 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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BullFrog Ultimate Sheer Protection

BullFrog Ultimate Sheer Protection Face Sunscreen

Active Ingredients 

Avobenzone 3%
Homosalate 12%
Octisalate 5%
Octocrylene 5%

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

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

water, cyclopentasiloxane, VP/eicosene copolymer, nylon-12, cetyl dimethicone, glyceryl stearate, methyl gluceth-20 camellia sinensis leaf extract, camellia oleifera leaf extract, saccharum officinarum (sugar cane) extract, citrus medica limonum (lemon) fruit extract, citrus aurantium dulcis (orange) fruit extract, pyrus malus (apple) fruit extract, glycerin, aloe barbadensis leaf juice, tocopheryl acetate, cetyl alcohol, lavandula angustifolia (lavender) extract, chamomilla recutita (matricaria) flower extract, rosmarinus officinalis (rosemary) leaf extract, acacia farnesiana flower extract, phenoxyethanol, polyacrylamide, steareth-21, C13-14 isoparaffin, methylparaben, steareth-2, fragrance, propylene glycol, EDTA, potassium hydroxide, propylparaben, benzyl alcohol, dimethicone/vinyl dimethicone crosspolymer, laureth-7, isopropyl myristate (283-047)

 

Dist. by Chattem, Inc. © 2009
P.O. Box 2219,
Chattanooga, TN 37409-0219 USA
www.bullfrogsunblock.com 
0033402-01



BullFrog Ultimate Sheer Protection Sunscreen

Active Ingredients

Avobenzone 3%
Homosalate 12%
Octisalate 5%
Octocrylene 5%

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

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

water, cyclopentasiloxane, VP/eicosene copolymer, nylon-12, cetyl dimethicone, glyceryl stearate, methyl gluceth-20, aloe barbadensis leaf juice, tocopheryl acetate, cetyl alcohol, glycerin, lavandula angustifolia (lavender) extract, chamomilla recutita (matricaria) flower extract, rosmarinus officinalis (rosemary) leaf extract, acacia farnesiana flower extract, saccharum officinarum (sugar cane) extract, camellia sinensis leaf extract, camellia oleifera leaf xetract, citrus medica limonum (lemon) fruit extract, citrus aurantium dulcis (orange) fruit extract, pyrus malus (apple) fruit extract, phenoxyethanol, polyacrylamide, steareth-21, C13-14 isoparaffin, methylparaben, steareth-2, fragrance, propylene glycol, EDTA, potassium hydroxide, propylparaben, benzyl alcohol, dimethicone/vinyl dimethicone crosspolymer, laureth-7, isopropyl myristate (283-048) 



Dist. by Chattem, Inc. © 2009
P.O. Box 2219,
Chattanooga, TN 37409-0219 USA
www.bullfrogsunblock.com 
0033410-01

Principal Display Panel

NEW
Bull
Frog® 
ultimate
sheer protection TM 
broad spectrum sunblock
spf 
30
FACE
ultra-light, oil-free lotion
Nurture Replenish Protect
7 botanicals, 6 moisturizers
& 4 antioxidants
Long Lasting UVA/UVB Protection
Waterproof & Sweatproof
Hypoallergenic Won’t Clog Pores
Anti-Aging Complex
NET WT 3 OZ (85 g)

Principal Display Panel - NET WT 3 OZ (85 g)

Principal Display Panel

NEW
Bull

Frog® 
ultimate
sheer protection TM 
broad spectrum
sunblock
spf 
30
ultra-light, oil-free lotion
Nurture Replenish Protect
7 botanicals, 6 moisturizers
& 4 antioxidants

Long Lasting UVA/UVB Protection
Waterproof & Sweatproof
Hypoallergenic Non-Greasy Formula
NET WT 5 OZ (141 g)

Principal Display Panel - NET WT 5 OZ (141 g)


BULLFROG ULTIMATE SHEER PROTECTION FACE 
avobenzone and homosalate and octisalate and octocrylene lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-3316
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 0.03 g  in 1 g
HOMOSALATE (HOMOSALATE) HOMOSALATE 0.12 g  in 1 g
OCTISALATE (OCTISALATE) OCTISALATE 0.05 g  in 1 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 0.05 g  in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER  
GLYCERYL MONOSTEARATE  
GREEN TEA LEAF  
SUGARCANE  
GLYCERIN  
ALOE VERA LEAF  
.ALPHA.-TOCOPHEROL ACETATE, DL-  
CETYL ALCOHOL  
LAVENDER EXTRACT  
CHAMOMILE  
ROSEMARY  
PHENOXYETHANOL  
C13-14 ISOPARAFFIN  
METHYLPARABEN  
PROPYLENE GLYCOL  
EDETIC ACID  
POTASSIUM HYDROXIDE  
PROPYLPARABEN  
BENZYL ALCOHOL  
ISOPROPYL MYRISTATE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41167-3316-0 85 g in 1 TUBE None
2 NDC:41167-3316-4 141 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 12/01/2009

Labeler - Chattem, Inc. (003336013)
Establishment
Name Address ID/FEI Operations
Chattem Plant 1 003336013 ANALYSIS, LABEL, MANUFACTURE, PACK, RECOVERY, RELABEL, REPACK

Revised: 01/2010 Chattem, Inc.



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


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