GOODSENSE SUNSCREEN SPF 70- avebenzone, homosalate, octisalate, oxybenzone lotion

GoodSense Sunscreen SPF 70 by

Drug Labeling and Warnings

GoodSense Sunscreen SPF 70 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 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

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 high and other sun protection measures including:

• 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
• May stain fabric

Inactive Ingredients

Water, Glycerin, C28-52 Olefin/Undecylenic Acid Copolymer, Neopentyl Glycol Diheptanoate, Polyglyceryl -3 Methylglucose Distearate, Tapioca Starch, Glyceryl Stearate, PEG-I00 Stearate, Phenethyl Benzoate, Microcrystalline Cellulose, Cellulose Gum, Tocopheryl Acetate, Fragrance, Stearic Acid, Polymethylsilsesquioxane, Caprylyl Glycol, Aloe Barbadensis Leaf Juice, Stearyl Alcohol, Dimethicone, Disodium EDTA, Sodium Hydroxide, Phenoxyethanol

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 *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 70

• Water Resistant (80 Minutes)
• UVA/UVB Protection
• Hypoallergenic

Compare to active ingredients of Coppertone

100% Satisfaction Guaranteed

8 FL OZ (237 mL)

INGREDIENTS AND APPEARANCE

GOODSENSE SUNSCREEN SPF 70 
avebenzone, homosalate, octisalate, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70281-661
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
UNDECYLENIC ACID (UNII: K3D86KJ24N)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
STARCH, TAPIOCA (UNII: 24SC3U704I)
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
PHENETHYL BENZOATE (UNII: 0C143929GK)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
STEARIC ACID (UNII: 4ELV7Z65AP)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DIMETHICONE (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70281-661-24	237 g in 1 CONTAINER; Type 0: Not a Combination Product	03/22/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/22/2019

Labeler - Solskyn Personal Care LLC (080010329)

Establishment
Name	Address	ID/FEI	Business Operations
Accra Pac, Inc.		024213616	manufacture(70281-661)