Label: SOLEIL TOUJOURS PERPETUAL RADIANCE BROAD SPECTRUM SPF 20- titanium dioxide and zinc oxide lotion
-
Contains inactivated NDC Code(s)
NDC Code(s): 58443-0185-2 - Packager: Prime Enterprises, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 January 17, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
-
Inactive Ingredients
Acrylates Copolymer, Algin, Aloe Barbadensis Leaf Juice, Alumina, Aluminum Hydroxide, Argania Spinosa Kernel Oil, Ascorbyl Palmitate, Beeswax, Bisabolol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Caramel, Ceramide 2, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Glycerin, Glyceryl Behenate/Eicosadioate, Glyceryl Caprylate, Glyceryl Undecylenate, Guanylcystamine HBr, Hexyl Laurate, Hydrated Silica, Hydrogen Dimethicone, Iron Oxides, Isododecane, Isopropyl Myristate, Laureth-7, Mica, Palmitoyl Hexapeptide-12, PEG-10 Phytosterol, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Porphyra Umbilicalis Extract, Propylene Carbonate, Punica Granatum Extract, Silica, Sodium Chloride, Sodium Hyaluronate, Sodium Metabisulfite, Squalane, Stearalkonium Hectorite, Stearic Acid, Superoxide Dismutase, Tetrahexyldecyl Ascorbate, Titanium Dioxide, Tocopheryl Acetate, Tribehenin, Vitis Vinifera (Grape) Seed Extract, Vitis Vinifera (Grape) Seed Oil, Water
- Warnings
-
Directions
- SHAKE WELL.
- Apply liberally 15 minutes before sun exposure
- Reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- 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 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
- Children under 6 months: Ask a doctor.
- Other information
- PRINCIPAL DISPLAY PANEL - 18mL Tube with Applicator
-
INGREDIENTS AND APPEARANCE
SOLEIL TOUJOURS PERPETUAL RADIANCE BROAD SPECTRUM SPF 20
titanium dioxide and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0185 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 17.6 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 41.2 mg in 1 mL Inactive Ingredients Ingredient Name Strength BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ALUMINUM OXIDE (UNII: LMI26O6933) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) 12-HYDROXYSTEARIC ACID (UNII: 933ANU3H2S) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) STEARALKONIUM HECTORITE (UNII: OLX698AH5P) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR) PROPYLENE CARBONATE (UNII: 8D08K3S51E) ALOE VERA LEAF (UNII: ZY81Z83H0X) ARGAN OIL (UNII: 4V59G5UW9X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) LEVOMENOL (UNII: 24WE03BX2T) YELLOW WAX (UNII: 2ZA36H0S2V) TRIBEHENIN (UNII: 8OC9U7TQZ0) CERAMIDE 2 (UNII: C04977SRJ5) .BETA.-SITOSTEROL (UNII: S347WMO6M4) PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C) CARAMEL (UNII: T9D99G2B1R) CETYL DIMETHICONE 150 (UNII: 5L694Y0T22) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) GLYCERYL MONOUNDECYLENATE (UNII: IK8A76Q5G8) GUANYLCYSTAMINE HYDROBROMIDE (UNII: PF69H864I0) FERRIC OXIDE RED (UNII: 1K09F3G675) ISODODECANE (UNII: A8289P68Y2) LAURETH-7 (UNII: Z95S6G8201) MICA (UNII: V8A1AW0880) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HEXYL LAURATE (UNII: 4CG9F9W01Q) SODIUM CHLORIDE (UNII: 451W47IQ8X) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SODIUM METABISULFITE (UNII: 4VON5FNS3C) SQUALANE (UNII: GW89575KF9) ORGOTEIN (UNII: PKE82W49V1) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) HYDRATED SILICA (UNII: Y6O7T4G8P9) SODIUM ALGINATE (UNII: C269C4G2ZQ) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) GRAPE SEED OIL (UNII: 930MLC8XGG) VITIS VINIFERA SEED (UNII: C34U15ICXA) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PORPHYRA UMBILICALIS (UNII: 14AN0J70WO) PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D) WATER (UNII: 059QF0KO0R) Product Characteristics Color brown Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0185-2 18 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 07/16/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 07/16/2015 Labeler - Prime Enterprises, Inc. (101946028) Registrant - Prime Enterprises, Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises, Inc. 101946028 label(58443-0185) , pack(58443-0185) , manufacture(58443-0185) , analysis(58443-0185)
