GOODAL GREEN TANGERINE VITA C DARK SPOT UV DEFENSE SUNSCREEN SPF50- homosalate, octocrylene, octisalate, avobenzone cream

goodal GREEN TANGERINE VITA C DARK SPOT UV DEFENSE SUNSCREEN SPF50 by

Drug Labeling and Warnings

goodal GREEN TANGERINE VITA C DARK SPOT UV DEFENSE SUNSCREEN SPF50 by is a Otc medication manufactured, distributed, or labeled by CLIO COSMETICS Co., Ltd., Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Homosalate 9.50%

Octocrylene 9.00%

Octisalate 4.75%

Avobenzone 2.85%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn
If used as directed with other sun protection measures (see Directions) decrease the risk of skin cancer and early skin aging caused by the sun

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure
Reapply at least every two hours
Use a water-resistant sunscreen if swimming or sweating

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 value of 15 or higher and other sun protection measures including: 1) Limit time in the sun, especially from 10 a.m. to 2 p.m. 2) Wear long-sleeved shirts, pants, hats, and sunglasses

WARNINGS

For external use only.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

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

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

INACTIVE INGREDIENT

Water, Citrus Tangerina (Tangerine) Extract, Butylene Glycol, Propanediol, Ethylhexyl Methoxycrylene, Silica, Butyloctyl Salicylate, Niacinamide, Pentylene Glycol, Polyglyceryl-3 Distearate, 1,2-Hexanediol, Arbutin, Potassium Cetyl Phosphate, Cetearyl Olivate, Cetyl Alcohol, Sorbitan Olivate, Hydroxyacetophenone, Carbomer, Tromethamine, Xanthan Gum, Glyceryl Stearate Citrate, Glycerin, Ethylhexylglycerin, Acetyl Glucosamine, Sodium Hyaluronate, Cynanchum Atratum Extract, Sodium Hyaluronate Crosspolymer, Althaea Rosea Flower Extract, Caprylyl Glycol, Allantoin, Ascorbic Acid, Ascorbyl Glucoside, Madecassoside, Panthenol, Tocopherol

OTHER SAFETY INFORMATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GOODAL GREEN TANGERINE VITA C DARK SPOT UV DEFENSE SUNSCREEN SPF50 
homosalate, octocrylene, octisalate, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84532-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	95 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	47.5 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	90 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	28.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TANGERINE (UNII: KH3E3096OO)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPANEDIOL (UNII: 5965N8W85T)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
NIACINAMIDE (UNII: 25X51I8RD4)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ARBUTIN (UNII: C5INA23HXF)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETYL ALCOHOL (UNII: 936JST6JCN)
SORBITAN OLIVATE (UNII: MDL271E3GR)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROMETHAMINE (UNII: 023C2WHX2V)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
VINCETOXICUM ATRATUM ROOT (UNII: 7DQZ24B35Y)
ALCEA ROSEA FLOWER (UNII: 1250O8MKPZ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
MADECASSOSIDE (UNII: CQ2F5O6YIY)
PANTHENOL (UNII: WV9CM0O67Z)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84532-001-02	1 in 1 CARTON	04/16/2025
1	NDC: 84532-001-01	50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/16/2025

Labeler - CLIO COSMETICS Co., Ltd. (689115249)

Registrant - CLIO COSMETICS Co., Ltd. (689115249)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(84532-001)