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

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.

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BullFrog SPF 50 Land Sport Quik Gel Sunscreen

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

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

Principal Display Image

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58443-0235-4	147 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/29/2016	12/31/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/29/2016	12/31/2018

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

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

Revised: 4/2022

Document Id: dbd987d2-c203-9206-e053-2a95a90a9e5a

Set id: 33c0753f-5ebf-3780-e054-00144ff88e88

Version: 3

Effective Time: 20220404

Prime Enterprises Inc.