Label: RGO DAILY ESSENCE SUN- octinoxate, titanium dioxide cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 81897-501-01 - Packager: SugarEn Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated May 28, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient(s)
- Purpose
- Use(s)
-
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
- Do not use
- Stop use and ask a doctor
- Keep out of reach of children
- Other Information
- Directions
-
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 creamProduct 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)
