DEET FREE BULLFROG Mosquito Coast Sunscreen with Insect Repellent SPF 30

Dosage form: spray
Ingredients: OCTINOXATE 75mg in 1mL, OCTOCRYLENE 100mg in 1mL, OXYBENZONE 60mg in 1mL, OCTISALATE 50mg in 1mL
Labeler: Chattem, Inc.
NDC Code: 41167-3307

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.

DEET FREE BULLFROG Mosquito Coast Sunscreen with Insect Repellent SPF 30

DEET FREE BULLFROG Mosquito Coast Sunscreen with Insect Repellent SPF 30

Active Ingredients

Oxtinoxate (7.5%), Octisalate (5%), Octocrylene (10%), Oxybenzone (6%)

Purpose

Sunscreens

Use

helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only.

Do not use: on damaged or broken skin.

When using this product: keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if: rash occurs

Flammable:

  • do not use near heat, flame or while smoking
  • avoid long term storage above 104 degrees F (40 degrees C)
  • do not puncture or incinerate
Contents under pressure
  • do not store at temperatures above 120 degrees F (49 degrees C)

Keep out of reach of children.

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

Directions
  • apply liberally 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • children under 6 months: ask a doctor 

Other Information

protect the product in this container from excessive heat and direct sun

Inactive Ingredients

acrylates/octylacrylamide copolymer, aloe barbadensis leaf extract, C12-15 alkyl benzoate, fragrance, isopropyl myristate, isopropyl palmitate, sd alcohol 40 (49.08% w/w),tocopheryl acetate (309-022)

Insect Repellent Directions For Use:

It is a violation of Federal law to use this product in a manner inconsistent with its labeling. Apply liberally and evenly over dry, exposed skin. Do not spray directly on face. Spray on palm of hand and apply to face. An adult must apply this product to children under 10. For continued protection from mosquitoes, reapply after 8 hours. For sunscreen protection, reapply after toweling off or as needed. Do not exceed 7 applications per day for adults, 3 applications per day for children.

Precautionary Statements: Hazards To Humans: Caution: For external use only. Causes moderate eye irritation.

FIRST AID:

If in eyes:

  • Hold eye open and rinse slowly and gently with water for 15-20 minutes.
  • Remove contact lenses, if present, after the first 5 minutes, then continue rinsing the eye.
  • Call a poison control center or doctor for treatment advice.

Have the product container or label with you when calling a poison control center or doctor, or going for treatment. You may also contact 1-800-222-1222 for emergency medical treatment information.

Storage:

Store in a cool, dry place. Avoid long term storage above 104 degrees F (40 degrees C). Do not store at temperatures above 120 degrees F (49 degrees C).

DisposalDo Not Puncture or Incinerate!

If empty: Nonrefillable container. Do not reuse or refill this container. Place in trash or offer for recycling if available.

If partly filled: Call your local solid waste agency or 1-800-CLEANUP for disposal instructions.

PHYSICAL OR CHEMICAL HAZARDS:
Flammable. Contents under pressure. Keep away from heat, sparks and open flame. Do not puncture or incinerate container. Exposure to temperatures above 130ºF may cause bursting. Avoid contact with plastics.

DEET FREE BULLFROG Mosquito Coast Sunscreen with Insect Repellent SPF 30 177ml
DEET FREE BULLFROG MOSQUITO COAST SUNSCREEN WITH INSECT REPELLENT SPF 30  
octinoxate, octisalate, octocrylene, oxybenzone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-3307
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE75 mg  in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE100 mg  in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE60 mg  in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
ALKYL (C12-15) BENZOATE 
ISOPROPYL MYRISTATE 
ISOPROPYL PALMITATE 
.ALPHA.-TOCOPHEROL ACETATE, D- 
ALCOHOL 
Packaging
#Item CodePackage Description
1NDC:41167-3307-3177 mL in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35212/06/2012
Labeler - Chattem, Inc. (003336013)
Establishment
NameAddressID/FEIOperations
Formulated Solutions, LLC143266687manufacture(41167-3307)

Revised: 12/2012
 
Chattem, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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