Label: BULL FROG SPF 50 QUIK WITH WATER ARMOR TECH- avobenzone, homosalate, octisalate, octocrylene aerosol, spray
- NDC Code(s): 77714-006-25
- Packager: BULLFROG BRANDS, LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 March 16, 2023
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- FLAMMABLE:
- Do not use
- When using this product
- Stop use and ask doctor if
- Keep out of reach of children.
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Directions
•Spray liberally and spread evenly by hand 15 minutes before sun exposure
•Hold can 4 to 6 inches away from skin to apply
•Do not spray directly into face. Spray into hand then apply to face.•Do not apply in windy conditions
•Use in a well-ventilated area
reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours- children under 6 months: Ask a doctor
- Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m. - 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses - Other Information
- Inactive ingredients
- Label
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INGREDIENTS AND APPEARANCE
BULL FROG SPF 50 QUIK WITH WATER ARMOR TECH
avobenzone, homosalate, octisalate, octocrylene aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77714-006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 50 mg in 1 g Inactive Ingredients Ingredient Name Strength ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK) ISOBUTANE (UNII: BXR49TP611) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) TRISILOXANE (UNII: 9G1ZW13R0G) ALCOHOL (UNII: 3K9958V90M) ASCORBYL PALMITATE (UNII: QN83US2B0N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77714-006-25 170 g in 1 CAN; Type 0: Not a Combination Product 03/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 03/01/2022 Labeler - BULLFROG BRANDS, LLC. (117426500)
