BullFrog SPF50 Land Sport C-Spray: Package Insert and Label Information

BULLFROG SPF50 LAND SPORT C-SPRAY- avobenzone, homosalate, octisalate, octocrylene and oxybenzone spray
SolSkyn Personal Care LLC

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.

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 (71.45% 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
LandsportSPF 50

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

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70281-333 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (AVOBENZONE) AVOBENZONE 2 g in 100 g HOMOSALATE (HOMOSALATE) HOMOSALATE 10 g in 100 g OCTISALATE (OCTISALATE) OCTISALATE 5 g in 100 g OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 2 g in 100 g OXYBENZONE (OXYBENZONE) OXYBENZONE 5 g in 100 g

Inactive Ingredients Ingredient Name Strength VACHELLIA FARNESIANA FLOWER .ALPHA.-TOCOPHEROL ACETATE, D- CAMELLIA OLEIFERA LEAF CHAMAEMELUM NOBILE FLOWER DIMETHYL CAPRAMIDE GLYCERIN ISOPROPYL MYRISTATE LAVANDULA ANGUSTIFOLIA FLOWER POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) PROPYLENE GLYCOL ROSEMARY ALCOHOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70281-333-11 170 g in 1 CONTAINER None

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)

Revised: 08/2017 SolSkyn Personal Care LLC