RGO DAILY ESSENCE SUN- octinoxate, titanium dioxide cream

RGO DAILY ESSENCE SUN by

Drug Labeling and Warnings

RGO DAILY ESSENCE SUN by is a Otc medication manufactured, distributed, or labeled by SugarEn Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(s)

Octinoxate 7.5%

Titanium Dioxide 1.05%

Purpose

Sun screen(UV protection)

Use(s)

Helps prevent sunburn.

Warnings

For external only.

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 shrits, pants, hat and sunglasses.

Children under 6 months of age: ask a doctor.

When using this product

keep out of eyes and mouth.

Do not use

on damaged or broken skin.

Stop use and ask a doctor

if irritation or rashes occurs.

Keep out of reach of children

Keep out of reach of children.

Other Information

Do not store in direct sunlight.

Directions

Apply liberally 15 minutes before sun exposure.

reapply at least every 2 hours.

Use a water resistant suncreen if swimming or sweating.

Inactive indredients

Water, Squalane, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Simmondsia Chinensis (Jojoba) Seed Oil, Cyclopentasiloxane, Phenoxyethanol, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Arachidyl Alcohol, Tocopheryl Acetate, Bisabolol, Magnesium Aluminum Silicate, Isohexadecane, Methylparaben, Tributyl Citrate, Cetyl Palmitate, Cetearyl Glucoside, Behenyl Alcohol, Fragrance, Cyclohexasiloxane, Aluminum Stearate, Polysorbate 80, Polyhydroxystearic Acid, Arachidyl Glucoside, Sodium Benzotriazolyl Butylphenol Sulfonate, Alumina, Dimethicone Crosspolymer, Sorbitan Oleate, Dimethicone, Panax Ginseng Root Extract, Sodium Hyaluronate, Buteth-3, 1,2-Hexanediol, Laureth-23, BHT, Cyclotetrasiloxane, Laureth-4, Ethylhexylglycerin, Alpha-Isomethyl Ionone, Citronellol, Limonene, Eugenol, Linalool, Butylphenyl Methylpropional

Package Label

INGREDIENTS AND APPEARANCE

RGO DAILY ESSENCE SUN 
octinoxate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81897-501
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.05 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LEVOMENOL (UNII: 24WE03BX2T)
BUTETH-3 (UNII: OC116GRO69)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
LAURETH-23 (UNII: N72LMW566G)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
EUGENOL (UNII: 3T8H1794QW)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
JOJOBA OIL (UNII: 724GKU717M)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
BEMOTRIZINOL (UNII: PWZ1720CBH)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
ASIAN GINSENG (UNII: CUQ3A77YXI)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
ISOHEXADECANE (UNII: 918X1OUF1E)
METHYLPARABEN (UNII: A2I8C7HI9T)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
SODIUM BENZOTRIAZOLYL BUTYLPHENOL SULFONATE (UNII: 0LA2QC9O3Z)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
LAURETH-4 (UNII: 6HQ855798J)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TRIBUTYL CITRATE (UNII: 827D5B1B6S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
DOCOSANOL (UNII: 9G1OE216XY)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALUMINUM OXIDE (UNII: LMI26O6933)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
SQUALANE (UNII: GW89575KF9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81897-501-01	40 mL in 1 TUBE; Type 0: Not a Combination Product	05/28/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/28/2021

Labeler - SugarEn Co., Ltd. (694215656)

Registrant - SugarEn Co., Ltd. (694215656)

Establishment
Name	Address	ID/FEI	Business Operations
SugarEn Co., Ltd.		694215656	manufacture(81897-501)