BULLFROG SPF50 WATER SPORT C-SPRAY- avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray

BullFrog SPF50 Water Sport C-Spray by

Drug Labeling and Warnings

BullFrog SPF50 Water Sport C-Spray by is a Otc medication manufactured, distributed, or labeled by SolSkyn Personal Care LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Product

BullFrog SPF50 Land Sport C-Spray

Active Ingredients

Avobenzone 2%, Homosalate 10%, Octisalate 5%, Octocrylene 2%, Oxybenzone 5%

Purpose

Sunscreen

Uses

• helps prevent sunburn
  
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

• For external use only
  
• Flammable: keep away from fire or flame. Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120°F.

Do not use

• on damaged or broken skin.

When using this product:

• keep away from face to avoid breathing in
  
• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children.

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

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
  
• 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

Other information

• for use on skin only
  
• protect this product from excessive heat and direct sun

Inactive Ingredients

Acacia Farnesiana Extract, Acrylates/Octylacrylamide Copolymer, Camellia Oleifera (Green Tea) Leaf Extract, Chamomile Flower Extract, Dimethyl Capramide, Fragrance, Glycerin, Isopropyl Myristate, Lavender Extract, Polyester-8, Propylene Glycol, Rosemary Leaf Extract, SD Alcohol 40 (72.45% w/w)

Questions or comments?

www.bullfrogsunscreen.com or call toll-free 1-800-715-3485

MAY STAIN SOME FABRICS, PLASTICS AND WOOD SURFACES.

PRINCIPAL DISPLAY PANEL

Bull Frog
Sunscreen
Landsport
SPF 50

INGREDIENTS AND APPEARANCE

BULLFROG SPF50 WATER SPORT C-SPRAY 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray

Product 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)