TONE BLUR ESSENCE SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene cream

Tone Blur Essence Sunscreen by

Drug Labeling and Warnings

Tone Blur Essence Sunscreen by is a Otc medication manufactured, distributed, or labeled by RBGROUP Co., Ltd, reBom Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 8.7%

PURPOSE

Sunscreen

INDICATIONS & USAGE

■ 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

■ on damaged skin 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 swallowed, get medical help or contact a Poison Control Center right away.

OTHER SAFETY INFORMATION

■ Protect this product from excessive heat and direct sun.

DOSAGE & ADMINISTRATION

Directions
■ Apply liberally 15 minutes before sun exposure.

■ Use a water resistant sunscreen if swimming or swating.

■ Reapply at least every 2 hours.

■ 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, 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 10a.m. - 2 p.m. ■ Wear long-sleeve shirts, pants, hats, and sunglasses.

INACTIVE INGREDIENT

Water, Butyloctyl Salicylate, Dicaprylyl Carbonate, Cetearyl Alcohol, Cetearyl Glucosidde, Dipropylene Glycol, Sorbitan Olivate, Poly C10-30 Alkyl Acrylate, Polymethylsilsesquioxane, Niacinamide, Benzyl Glycol, Glyceryl Stearate SE, Panthenol, Arginine, Carbomer, Tocopherol, Butylene Glycol, Xanthan Gum, Hydroxypropyl Methylcellulose Stearoxy Ether, Ethylhexylglycerin, Glycerin, Adenosine, Ethyl Hexanediol, 1,2-Hexanediol, Centella Asiatica Extract, Madecassic Acid, Asiaticoside, Asiatic Acid, Aloe Barbadensis Leaf Juice, Sodium Hyaluronate

PDP_Tone Blur Essence Sunscreen

INGREDIENTS AND APPEARANCE

TONE BLUR ESSENCE SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84326-124
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4.35 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
ADENOSINE (UNII: K72T3FS567)
ASIATIC ACID (UNII: 9PA5A687X5)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U)
NIACINAMIDE (UNII: 25X51I8RD4)
ETHYLENE GLYCOL MONOBENZYL ETHER (UNII: 06S8147L47)
GLYCERIN (UNII: PDC6A3C0OX)
MADECASSIC ACID (UNII: M7O1N24J82)
HYPROMELLOSE 2208 0.45% STEAROXY ETHER (UNII: MG58AH4FJ8)
POLYACRYLIC ACID (800000 MW) (UNII: D0I6NSZ87U)
ASIATICOSIDE (UNII: PKO39VY215)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
ARGININE (UNII: 94ZLA3W45F)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
WATER (UNII: 059QF0KO0R)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SORBITAN OLIVATE (UNII: MDL271E3GR)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
XANTHAN GUM (UNII: TTV12P4NEE)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PANTHENOL (UNII: WV9CM0O67Z)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ETHOHEXADIOL (UNII: M9JGK7U88V)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84326-124-01	50 mL in 1 TUBE; Type 0: Not a Combination Product	05/14/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/14/2024

Labeler - RBGROUP Co., Ltd (987610097)

Establishment
Name	Address	ID/FEI	Business Operations
reBom Co., Ltd		695951708	manufacture(84326-124)