Label: BULLFROG DEET FREE MOSQUITO COAST SUNSCREEN WITH INSECT REPELLENT SPF 30- octinoxate, octisalate, octocrylene and oxybenzone spray
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Contains inactivated NDC Code(s)
NDC Code(s): 70281-311-11, 70281-311-12 - Packager: SolSkyn Personal Care LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated February 15, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Use
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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
- Directions
- Other information
- Inactive Ingredients
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Questions or comments?
www.bullfrogsunscreen.com or call toll-free 1-800-715-3485
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, re-apply after 8 hours. 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. Do not get in eyes. Use on children under 6 months of age only with the advice of a physician.
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 130°F may cause bursting. Avoid contact with plastics.
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°F (40°C). Do not store at temperatures above 120°F (49°C).
DISPOSAL: Do 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.
MAY STAIN SOME FABRICS, PLASTICS AND WOOD SURFACES.
EPA Reg. No.: 89523-1
EPA Est. No.: 54487-GA-001 - Hold eye open and rinse slowly and gently with water for 15-20 minutes.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BULLFROG DEET FREE MOSQUITO COAST SUNSCREEN WITH INSECT REPELLENT SPF 30
octinoxate, octisalate, octocrylene and oxybenzone sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70281-311 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) ALCOHOL (UNII: 3K9958V90M) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70281-311-11 177 g in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2014 2 NDC:70281-311-12 177 g in 1 CAN; Type 0: Not a Combination Product 01/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/01/2014 Labeler - SolSkyn Personal Care LLC (080010329)
