Label: SHISEIDO ULTIMATE SUN PROTECTION- avobenzone, octinoxate, octocrylene, and oxybenzone cream
- NDC Code(s): 58411-359-10, 58411-359-11
- 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 December 13, 2018
If you are a consumer or patient please visit this version.
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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 2 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∙DIMETHICONE∙SD ALCOHOL 40-B∙TALC∙METHYL METHACRYLATE CROSSPOLYMER∙ISODODECANE∙CETYL ETHYLHEXANOATE∙DIISOPROPYL SEBACATE∙TRIETHYLHEXANOIN∙LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE∙GLYCERIN∙DEXTRIN PALMITATE∙SUCROSE TETRASTEARATE TRIACETATE∙POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER∙TRIMETHYLSILOXYSILICATE∙XYLITOL∙SILICA∙SODIUM CHLORIDE∙PEG/PPG-14/7 DIMETHYL ETHER∙SAXIFRAGA SARMENTOSA EXTRACT∙SOPHORA ANGUSTIFOLIA ROOT EXTRACT∙DISTEARDIMONIUM HECTORITE∙ISOSTEARIC ACID∙CALCIUM STEARATE∙TRISODIUM EDTA∙VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER∙ALCOHOL∙BHT∙BUTYLENE GLYCOL∙STEARIC ACID∙SODIUM METABISULFITE∙SYZYGIUM JAMBOS LEAF EXTRACT∙TOCOPHEROL∙POLYSILICONE-2∙METHYLPARABEN∙FRAGRANCE∙IRON OXIDES∙
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
SHISEIDO ULTIMATE SUN PROTECTION
avobenzone, octinoxate, octocrylene, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-359 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1288 mg in 50 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2524 mg in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2575 mg in 50 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 1545 mg in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) TALC (UNII: 7SEV7J4R1U) ISODODECANE (UNII: A8289P68Y2) CETYL ETHYLHEXANOATE (UNII: 134647WMX4) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) GLYCERIN (UNII: PDC6A3C0OX) DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3) SUCROSE TETRASTEARATE TRIACETATE (UNII: 1K7LBQ045N) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) XYLITOL (UNII: VCQ006KQ1E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ISOSTEARIC ACID (UNII: X33R8U0062) CALCIUM STEARATE (UNII: 776XM7047L) EDETATE TRISODIUM (UNII: 420IP921MB) VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) ALCOHOL (UNII: 3K9958V90M) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM METABISULFITE (UNII: 4VON5FNS3C) SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) 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:58411-359-10 1 in 1 CARTON 02/01/2018 1 50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:58411-359-11 1 in 1 CARTON 02/01/2018 2 100 mL in 1 BOTTLE, PLASTIC; 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 02/01/2018 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICA INC. 782677132 manufacture(58411-359) , analysis(58411-359)
