Label: BULLFROG SPF50 WATER SPORT C-SPRAY- avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray
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Contains inactivated NDC Code(s)
NDC Code(s): 70281-323-11 - 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 August 7, 2017
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
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Directions
- shake well. Hold can 4-6 inches from skin to apply.
- spray liberally and spread evenly by hand 15 minutes before sun exposure on all exposed areas. Ensure skin is completely covered with product.
- do not spray directly on face. Spray on hands then apply to face.
- do not apply in windy conditions.
- use in a well-ventilated area.
- re-apply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
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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 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
- children under 6 months: ask a doctor
- shake well. Hold can 4-6 inches from skin to apply.
- Other information
- Inactive Ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BULLFROG SPF50 WATER SPORT C-SPRAY
avobenzone, homosalate, octisalate, octocrylene, oxybenzone sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70281-323 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5 g in 100 g Inactive Ingredients Ingredient Name Strength VACHELLIA FARNESIANA FLOWER (UNII: 8487B3MG6D) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ROSEMARY (UNII: IJ67X351P9) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70281-323-11 170 g in 1 CONTAINER; Type 0: Not a Combination Product 09/15/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 09/15/2015 Labeler - SolSkyn Personal Care LLC (080010329)