DOMINAS DARK SPOT UV DEFENSE SUNSCREEN BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene cream

Dominas Dark Spot UV Defense Sunscreen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Dominas Dark Spot UV Defense Sunscreen Broad Spectrum SPF 50 by is a Otc medication manufactured, distributed, or labeled by fmg Co.Ltd, LG H&H Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Avobenzone 2.7%
Homosalate 9.0%
Octisalate 4.5%
Octocrylene 9.0%

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

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

STOP USE

Stop use and ask doctorif 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
• children under 6 months: Ask a doctor
• reapply at least every 2 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:

- limit time in the sun, especially from 10 a.m. - 2 p.m.

- wear long-sleeved shirts, pants, hats, and sunglasses

INACTIVE INGREDIENTS

WATER, GLYCERIN, DIMETHICONE, CETEARYL ALCOHOL, ISODODECANE, POTASSIUM CETYL PHOSPHATE, ACRYLATES/POLYTRIMETHYLSILOXYMETHACRYLATE COPOLYMER, 1,2-HEXANEDIOL, BENZOTRIAZOLYL DODECYL P-CRESOL, PANTHENOL, GLYCERYL CAPRYLATE, GLYCERYL STEARATE, NIACINAMIDE, CAPRYLIC/CAPRIC TRIGLYCERIDE, MAGNESIUM ALUMINUM SILICATE, CETEARYL OLIVATE, INULIN LAURYL CARBAMATE, FRAGRANCE, SORBITAN OLIVATE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, XANTHAN GUM, DIPROPYLENE GLYCOL, TROMETHAMINE,
TRISODIUM EDTA, MYRISTICA FRAGRANS (NUTMEG) EXTRACT, PAEONOL, PAEONIA SUFFRUTICOSA BRANCH/FLOWER/LEAF EXTRAC

OTHER INFORMATION

• protect the product in this container from excessive heat and direct sun
• the product may stain certain types of fabrics

QUESTIONS?

1-866-993-4709

PRINCIPAL DISPLAY PANEL 50ml / 1.7 fl. oz Tube Carton

DOMINAS

DARK SPOT
UV DEFENSE
SUNSCREEN

BROAD SPECTRUM SPF 50

+ DERMATOLOGICALLY TESTED
+ VITAMIN B3

50 ml / 1.7 fl. oz

+ Dermatologically tested
+ Formulated without PABA
+ Fomulated without ethanol
+ Sheer & Lightweight Formula

MADE IN KOREA
DISTR. LG H&H Co., Ltd.
58, SAEMUNAN-RO, JONGNO-GU,
SEOUL, KOREA

PRINCIPAL DISPLAY PANEL 50ml / 1.7 fl. oz x 2 ea

DOMINAS

DARK SPOT
UV DEFENSE
SUNSCREEN

BROAD SPECTRUM SPF 50

+ DERMATOLOGICALLY TESTED
+ VITAMIN B3

50 ml / 1.7 fl. oz x 2 ea

+ Dermatologically tested
+ Formulated without PABA
+ Fomulated without ethanol
+ Sheer & Lightweight Formula

MADE IN KOREA
DISTR. LG H&H Co., Ltd.
58, SAEMUNAN-RO, JONGNO-GU,
SEOUL, KOREA

INGREDIENTS AND APPEARANCE

DOMINAS DARK SPOT UV DEFENSE SUNSCREEN BROAD SPECTRUM SPF 50 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72330-301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9 g  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.7 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72330-301-50	1 in 1 CARTON	10/30/2023
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 72330-301-52	2 in 1 CARTON	05/01/2024
2		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	10/30/2023

Labeler - fmg Co.Ltd (690188305)

Registrant - LG H&H Co.,Ltd. (688276187)

Establishment
Name	Address	ID/FEI	Business Operations
fmg Co.Ltd		690188305	manufacture(72330-301)