BULLFROG SPF50 WATER SPORT- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

BullFrog SPF50 Water Sport by

Drug Labeling and Warnings

BullFrog SPF50 Water Sport 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

BullFrog SPF50 Water Sport Lotion

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.

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.

Keep out of reach of children.

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

Directions

• apply liberally 15 minutes before sun exposure
  
• 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 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

• protect this product from excessive heat and direct sun

Inactive Ingredients

Acrylates Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Diisopropyl Adipate, Dimethyl Capramide, Disodium EDTA, Ethylhexylglycerin, Fragrance, Hydroxypropyl Methylcellulose, Macrocystis Pyrifera Extract, Phenoxyethanol, Polyester-8, Polyisobutene, Propylene Glycol, Silica, Sorbitan Oleate, Tocopheryl (Vitamin E) Acetate, Triethanolamine, Water

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
WATER SPORT
with Water Armor TECH
Lotion
50
BROAD SPECTRUM SPF 50
5 FL OZ (147 mL)

INGREDIENTS AND APPEARANCE

BULLFROG SPF50 WATER SPORT 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70281-324
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 mg  in 100 mg
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 mg  in 100 mg
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 100 mg
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 mg  in 100 mg
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
POLYISOBUTYLENE (1300 MW) (UNII: 241BN7J12Y)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70281-324-13	147 mg in 1 BOTTLE; 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)