BULLFROG SPF 50 LAND SPORT QUIK GEL SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone gel

BullFrog by

Drug Labeling and Warnings

BullFrog by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3% Homosalate 15% Octisalate 5%

Octocrylene 10% Oxybenzone 6%

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
• reapply:
• 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-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

Other Information

• protect this product from excessive heat and direct sun

INACTIVE INGREDIENT

Acacia Farnesiana Extract, Acrylates/Octylacrylamide Copolymer, Aloe Barbadensis Leaf Extract, Camellia Oleifera (Green Tea) Leaf Extract, Chamomile Flower Extract, Ciclohexasiloxane, Ciclopentasiloxane, Ethylhexyl Palmitate, Fragrance, Glycerin, Hydroxypropylcellulose, Isopropyl Myristate, Lavender Extract, Phenethyl Benzoate, PPG-12/SMDI Copolymer, Propylene Glycol, Rosemary Leaf Extract, SD Alcohol 40 (50.65% w/w), Tocopheryl (Vitamin E) Acetate

Questions or Comments?

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

BullFrog SPF 50 Land Sport Quik Gel Sunscreen

INGREDIENTS AND APPEARANCE

BULLFROG  SPF 50 LAND SPORT QUIK GEL SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, oxybenzone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0235
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	54 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	27 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	135 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	90 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PHENETHYL BENZOATE (UNII: 0C143929GK)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
ROSEMARY (UNII: IJ67X351P9)
VACHELLIA FARNESIANA FLOWER (UNII: 8487B3MG6D)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALCOHOL (UNII: 3K9958V90M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PPG-12 (UNII: L63N6V755Z)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
N-TERT-OCTYLACRYLAMIDE (UNII: 0U7G677BFR)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0235-4	147 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/29/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/29/2016

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc.		101946028	pack(58443-0235) , manufacture(58443-0235) , label(58443-0235) , analysis(58443-0235)