Label: SHISEIDO ULTIMATE SUN PROTECTOR- octisalate, homosalate, octocrylene, and avobenzone lotion
- NDC Code(s): 58411-481-10, 58411-481-11
- Packager: SHISEIDO AMERICAS CORPORATION
- 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 October 6, 2020
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
- 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
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Directions
For sunscreen use:
- apply liberally 15 minutes before sun exposure
- reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every two hours
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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
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Inactive Ingredients
:WATER▪DIISOPROPYL SEBACATE▪TALC▪METHYL METHACRYLATE CROSSPOLYMER▪DIMETHICONE▪PEG/PPG-9/2 DIMETHYL ETHER▪SD ALCOHOL 40-B▪LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE▪TRIETHYLHEXANOIN▪GLYCERIN▪DEXTRIN PALMITATE▪SUCROSE TETRASTEARATE TRIACETATE▪ISODODECANE▪PPG-3 DIPIVALATE▪TRIMETHYLSILOXYSILICATE▪SILICA▪SODIUM CHLORIDE▪PEG/PPG-14/7 DIMETHYL ETHER▪SAXIFRAGA SARMENTOSA EXTRACT▪CAMELLIA SINENSIS LEAF EXTRACT▪SOPHORA ANGUSTIFOLIA ROOT EXTRACT▪PPG-17▪DISTEARDIMONIUM HECTORITE▪CALCIUM STEARATE▪ISOSTEARIC ACID▪PALMITIC ACID▪TRISODIUM EDTA▪ALCOHOL▪SILICA DIMETHYL SILYLATE▪VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER▪PEG-6▪BHT▪TOCOPHEROL▪BUTYLENE GLYCOL▪STEARIC ACID▪SODIUM METABISULFITE▪SYZYGIUM JAMBOS LEAF EXTRACT▪POLYSILICONE-2▪METHYLPARABEN▪FRAGRANCE▪IRON OXIDES▪
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 150 mL Bottle Label
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INGREDIENTS AND APPEARANCE
SHISEIDO ULTIMATE SUN PROTECTOR
octisalate, homosalate, octocrylene, and avobenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-481 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 50 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 23 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) TALC (UNII: 7SEV7J4R1U) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q) DIMETHICONE (UNII: 92RU3N3Y1O) PEG/PPG-9/2 DIMETHYL ETHER (UNII: LM6Q66468X) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) GLYCERIN (UNII: PDC6A3C0OX) DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3) SUCROSE TETRASTEARATE TRIACETATE (UNII: 1K7LBQ045N) ISODODECANE (UNII: A8289P68Y2) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) GREEN TEA LEAF (UNII: W2ZU1RY8B0) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) PPG-17 (UNII: OV0Q322E0U) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) CALCIUM STEARATE (UNII: 776XM7047L) ISOSTEARIC ACID (UNII: X33R8U0062) PALMITIC ACID (UNII: 2V16EO95H1) EDETATE TRISODIUM (UNII: 420IP921MB) ALCOHOL (UNII: 3K9958V90M) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM METABISULFITE (UNII: 4VON5FNS3C) SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF) METHYLPARABEN (UNII: A2I8C7HI9T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-481-10 1 in 1 CARTON 01/01/2020 1 150 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:58411-481-11 1 in 1 CARTON 01/01/2020 2 50 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/01/2020 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICAS INC. 782677132 MANUFACTURE(58411-481) , ANALYSIS(58411-481)
