GOODSENSE SPF 30 SUNSCREEN- avobenzone 3%, homosalate 10%, octisalate 5%, octocrylene 10% lotion
Geiss, Destin, & Dunn, 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.

----------

GoodSense SPF 30 Sunscreen

Active Ingredients

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 10%

Purpose

Sunscreen

Uses

Helps prevent sunburn

Warnings

For external use only.

Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse eyes 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

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 n the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measure including:

limit time in the sun, especially from 10 am to 2 pm
wear long-sleeved shirts, pants, hats, and sunglasses.
Children under 6 months: ask a doctor.

Inactive Ingredients

Acrylates/Octylacrylamide Copolymer, Benzyl Alcohol, Caprylic/Capric Triglyceride, Chlorphenesin, Diethylhexyl Syringylidenemalonate, Disodium EDTA, Ethylhexyl Palmitate, Fragrance, Oleth-3, Polyamide-8, Sodium Ascorbyl Phosphate, Sorbitol, Tocopherol, Triethanolamine, Water.

Label

GOODSENSE SPF 30 SUNSCREEN
avobenzone 3%, homosalate 10%, octisalate 5%, octocrylene 10% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50804-221
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
TROLAMINE (UNII: 9O3K93S3TK)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
TOCOPHEROL (UNII: R0ZB2556P8)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
OLETH-3 (UNII: BQZ26235UC)
POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
SORBITOL (UNII: 506T60A25R)
CHLORPHENESIN (UNII: I670DAL4SZ)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50804-221-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/21/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	10/21/2019

Labeler - Geiss, Destin, & Dunn, Inc. (076059836)