NUBES SUN BLOCK- homosalate, octinoxate, octocrylene,, avobenzone cream

Nubes SUN BLOCK by

Drug Labeling and Warnings

Nubes SUN BLOCK by is a Otc medication manufactured, distributed, or labeled by UNIQUEMI, Kolmar Korea Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Homosalate 9.00% } ·········································Sunscreen

Octinoxate 6.80% } ···········································Sunscreen

Octisalate 4.50% } ············································Sunscreen

Octocrylene 4.00% } ·········································Sunscreen

Avobenzone 2.70% } ········································Sunscreen

INACTIVE INGREDIENT

Water, Propanediol, Butyloctyl Salicylate, Benzotriazolyl Dodecyl P-Cresol, Glycerin, Pentylene Glycol, 1,2-Hexanediol, Silica, Dimethicone/Vinyl Dimethicone Crosspolymer, Inulin Lauryl Carbamate, Vp/Eicosene Copolymer, Ammonium Acryloyldimethyltaurate/Vp Copolymer, Xanthan Gum, Ethylhexylglycerin,Iron Oxides(CI 77491), Iron Oxides(CI 77492), Bht, Tocophero

PURPOSE

helps prevent sunburn

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

Apply liberally and evenly 15 minutes before sun exposure.

Reapply: At least 80 minutes after swimming or sweating,

immediately after towel drying, at least every 2 hours.

For children under 6 months of age: Ask a doctor.

Sun Protection Measures. Spending time in the sun

increases your risk of skin cancer and early skin aging. To

decrease this risk, regulary use a sunscreen with a 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-sleeve shirts, pants, hats, and sunglasses.

WARNINGS

For extrernal use only.

Do not use on damaged or broken skin.

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

to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If product is swallowed,

get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

topical use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NUBES SUN BLOCK 
homosalate, octinoxate, octocrylene,, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84514-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6.8 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.7 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4 g  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84514-0001-1	52 mL in 1 CONTAINER; Type 0: Not a Combination Product	06/25/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/25/2024

Labeler - UNIQUEMI (690393808)

Registrant - UNIQUEMI (690393808)

Establishment
Name	Address	ID/FEI	Business Operations
UNIQUEMI		690393808	label(84514-0001)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd		963271745	manufacture(84514-0001)