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Name:Bullfrog Surfer
Manufacturer:Chattem, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


BullFrog Surfer Gel

BULLFROG SURFER - octinoxate, octocrylene and oxybenzone gel 
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 Surfer Gel

Drug Facts

Active ingredients

Octinoxate 7.5%

Octocrylene 10%

Oxybenzone 3%

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

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

aloe barbadensis leaf extract, beeswax, caprylic/capric triglyceride, cyclomethicone, fragrance, isopropyl myristate, isopropyl palmitate, isostearyl alcohol, silica, tocopheryl acetate (245-136)

PRINCIPAL DISPLAY PANEL

Bull Frog® 
SPF 36
Surfer FormulaTM 
Gel Sunblock
8 Hour Waterproof
UVA/UVB Protection
Sweatproof
Original Amphibious Formula
5 FL OZ (147 ML)

PRINCIPAL DISPLAY PANEL Bull Frog® SPF 36 Surfer Formula Gel Sunblock Original Amphibious Formula 5 FL OZ (147 ML)

BULLFROG SURFER 
octinoxate and octocrylene and oxybenzone gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-3301
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 0.075 g  in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 0.1 g  in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 0.03 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF  
YELLOW WAX  
CYCLOMETHICONE  
ISOPROPYL MYRISTATE  
ISOPROPYL PALMITATE  
ISOSTEARYL ALCOHOL  
SILICON DIOXIDE  
.ALPHA.-TOCOPHEROL ACETATE, D-  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41167-3301-7 147 mL in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 01/01/1989

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

Revised: 05/2011 Chattem, Inc.



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


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