RGO DAILY ESSENCE SUN- octinoxate, titanium dioxide cream 
SugarEn Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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81897-501 RGO DAILY ESSENCE SUN

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

​81897-501

RGO DAILY ESSENCE SUN 
octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81897-501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.05 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81897-501-0140 mL in 1 TUBE; Type 0: Not a Combination Product05/28/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/28/2021
Labeler - SugarEn Co., Ltd. (694215656)
Registrant - SugarEn Co., Ltd. (694215656)
Establishment
NameAddressID/FEIBusiness Operations
SugarEn Co., Ltd.694215656manufacture(81897-501)

Revised: 5/2021
Document Id: c3609f6d-d17b-79a0-e053-2995a90a8aab
Set id: c3609f6d-d17a-79a0-e053-2995a90a8aab
Version: 1
Effective Time: 20210528
 
SugarEn Co., Ltd.