GOODSENSE SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

GoodSense Sunscreen SPF 50 by

Drug Labeling and Warnings

GoodSense Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by Solskyn Personal Care LLC, Accra Pac, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients​

Avobenzone 3%

Homosalate 13%

Octisalate 5%

Octocrylene 7%

Oxybenzone 4%

Purpose

Sunscreen

Use

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.

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

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 the product in this container from excessive heat and direct sun May stain fabric

Inactive Ingredients:

Water, Glycerin, C28-52 Olefin/Undecylenic Acid Copolymer, Neopentyl Glycol Diheptanoate, Stearic Acid, Polyglyceryl-3 Methylglucose Distearate, Tapioca Starch, Glyceryl Stearate, PEG-100 Stearate, Microcrystalline Cellulose, Phenethyl Benzoate, Cellulose Gum, Tocopheryl Acetate, Fragrance, Polymethylsilsesquioxane, Caprylyl Glycol, Aloe Barbadensis Leaf Juice, Stearyl Alcohol, Dimethicone, Disodium EDTA, Sodium Hydroxide, Phenoxyethanol

Questions

Distributed by: Geiss, Destin & Dunn, Inc, Peachtree City, GA 30269

www.valuelabels.com/800-715-3485

GoodSense is a registered trademark of L. Perrigo Company

*This product is not manufactured or distributed by Bayer, the owner of the registered trademark Coppertone

Principal Display Panel

GOODSENSE

SUNSCREEN

LOTION

BROAD SPECTRUM

SPF 50

Water Resistant

(80 Minutes)

UVA/UVB Protection

Hypoallergenic

Compare to active ingredients of

Coppertone

100%

Satisfaction

Guaranteed

8 FL OZ (237 mL)

PKLA-41425-GFS1

INGREDIENTS AND APPEARANCE

GOODSENSE SUNSCREEN SPF 50 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70281-639
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	13 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
STARCH, TAPIOCA (UNII: 24SC3U704I)
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PHENETHYL BENZOATE (UNII: 0C143929GK)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
STEARIC ACID (UNII: 4ELV7Z65AP)
UNDECYLENIC ACID (UNII: K3D86KJ24N)
NEOPENTYL GLYCOL (UNII: QI80HXD6S5)
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70281-639-24	237 g in 1 CONTAINER; Type 0: Not a Combination Product	04/02/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/02/2019

Labeler - Solskyn Personal Care LLC (080010329)

Establishment
Name	Address	ID/FEI	Business Operations
Accra Pac, Inc.		024213616	manufacture(70281-639)