GOODSENSE SPF 30 SPORT CSPRAY COMFORT CAN- avobenzone, homosalate, octisalate, octocrylene spray

GoodSense SPF 30 Sport CSpray Comfort Can by

Drug Labeling and Warnings

GoodSense SPF 30 Sport CSpray Comfort Can by is a Otc medication manufactured, distributed, or labeled by Solskyn Personal Care LLC, KIK Piedmont LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 2.5%

Homosalate 10%

Octisalate 5%

Octocrylene 8%

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

Do not use

Do not use on damaged or broken skin.

When using this product

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

Stop use and ask a doctor if rash occurs.

Flammable

● do not use near heat, flame or while smoking ● avoid long –term storage above 104oF(40oC) ● do not puncture or incinerate ● contents under pressure ● do not store at temperature above 120oF(49oC)

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Hold 4-6 inches from skin and spray over arms, legs, and body in a continuous motion, then quickly rub into skin. Do not spray directly onto face; spray on hands and then apply to face.

• 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 ·

• Limit time in the sun, especially from 10a.m.-2 p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses.
• Children under 6 months: Ask a doctor.

Other Information

Protect the product in this container from excessive heat and direct sun

For use on skin only, avoid contact with fabric

Inactive Ingredients

Alcohol Denatured (66.04% w/w), Phenethyl Benzoate, Lauryl Lactate, Cyclopentasiloxane, Acrylates/Dimethicone Copolymer, Fragrance, Aloe Barbadensis Leaf Juice, Menthol, Tocopheryl Acetate

Questions

Distributed by:

Geiss, Destin & Dunn, Inc.

Peach tree City, GA 30269

www.valuelabels.com

800-715-3485

GoodSense® is a registered trademark of L. Perrigo Company

Principal Display Panel

GOODSENSE®

SUNSCREEN

CONTINUOUS

SPRAY

SPORT

BROAD SPECTRUM

SPF 30

Water Resistant (80 Minutes)
Spray at Any Angle
UVA/UVB Protection

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NET WT 5.5 OZ (155 g)

INGREDIENTS AND APPEARANCE

GOODSENSE SPF 30 SPORT CSPRAY COMFORT CAN 
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70281-613
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.5 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	8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MENTHOL (UNII: L7T10EIP3A)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALCOHOL (UNII: 3K9958V90M)
PHENETHYL BENZOATE (UNII: 0C143929GK)
LAURYL LACTATE (UNII: G5SU0BFK7O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70281-613-25	155 g in 1 CAN; Type 0: Not a Combination Product	04/03/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/03/2019

Labeler - Solskyn Personal Care LLC (080010329)

Establishment
Name	Address	ID/FEI	Business Operations
KIK Piedmont LLC		078482780	manufacture(70281-613)