Label: SHISEIDO ULTIMATE SUN PROTECTION- octinoxate, octocrylene, titanium dioxide, and zinc oxide cream
- NDC Code(s): 58411-254-60, 58411-254-61, 58411-254-62, 58411-254-80
- Packager: SHISEIDO AMERICAS CORPORATION
- 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 June 19, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
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
-
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
-
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
-
Inactive Ingredients
WATER•DIMETHICONE•SD ALCOHOL 40-B•ISOHEXADECANE•BUTYLENE GLYCOL•ISOPROPYL MYRISTATE•METHYL METHACRYLATE CROSSPOLYMER•LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE•XYLITOL•GLYCERIN•POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER•ISODODECANE•TRIMETHYLSILOXYSILICATE•DISTEARDIMONIUM HECTORITE•PEG-6•DEXTRIN PALMITATE•PEG-32•PEG/PPG-14/7 DIMETHYL ETHER•SAXIFRAGA SARMENTOSA EXTRACT•SCUTELLARIA BAICALENSIS ROOT EXTRACT•ONONIS SPINOSA ROOT EXTRACT•ECTOIN•SOPHORA ANGUSTIFOLIA ROOT EXTRACT•SILICA•HYDROGEN DIMETHICONE•CARBOXYDECYL TRISILOXANE•ALUMINUM HYDROXIDE•STEARIC ACID•TRISODIUM EDTA•POLYMETHYLSILSESQUIOXANE•TALC•ALCOHOL•BHT•SYZYGIUM JAMBOS LEAF EXTRACT•TOCOPHEROL•PHENOXYETHANOL•FRAGRANCE•
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
-
INGREDIENTS AND APPEARANCE
SHISEIDO ULTIMATE SUN PROTECTION
octinoxate, octocrylene, titanium dioxide, and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-254 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4255 mg in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1725 mg in 50 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 805 mg in 50 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 9430 mg in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) ISOHEXADECANE (UNII: 918X1OUF1E) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) XYLITOL (UNII: VCQ006KQ1E) GLYCERIN (UNII: PDC6A3C0OX) ISODODECANE (UNII: A8289P68Y2) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) ONONIS SPINOSA ROOT (UNII: FD2FMC53M1) ECTOINE (UNII: 7GXZ3858RY) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) EDETATE TRISODIUM (UNII: 420IP921MB) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) TALC (UNII: 7SEV7J4R1U) ALCOHOL (UNII: 3K9958V90M) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-254-60 1 in 1 CARTON 02/01/2015 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:58411-254-61 1 in 1 CARTON 02/01/2015 2 30 mL in 1 TUBE; Type 0: Not a Combination Product 3 NDC:58411-254-62 1 in 1 CARTON 02/01/2015 3 15 mL in 1 TUBE; Type 0: Not a Combination Product 4 NDC:58411-254-80 2 mL in 1 POUCH; Type 0: Not a Combination Product 02/01/2015 12/31/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/01/2015 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICA INC. 782677132 manufacture(58411-254) , analysis(58411-254)
