Label: SHISEIDO EXTRA SMOOTH SUN PROTECTION N- octinoxate, octocrylene, and zinc oxide cream
- NDC Code(s): 58411-348-60
- 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 December 27, 2019
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- 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
-
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, ISODODECANE, BUTYLENE GLYCOL, CYCLOMETHICONE, DIMETHICONE, POLYMETHYL METHACRYLATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, GLYCERIN, SD ALCOHOL 40-B, DISTEARDIMONIUM HECTORITE, XYLITOL, METHYL GLUCETH-10, SCUTELLARIA BAICALENSIS ROOT EXTRACT, ONONIS SPINOSA ROOT EXTRACT, ECTOIN, HYDROGENATED POLYDECENE, HYDROGEN DIMETHICONE, ISOSTEARIC ACID, TRISODIUM EDTA, SILICA, PEG-150, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, ALUMINA, BHT, TRIETHOXYCAPRYLYLSILANE, SYZYGIUM JAMBOS LEAF EXTRACT, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE, TITANIUM DIOXIDE,
- Other information
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
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INGREDIENTS AND APPEARANCE
SHISEIDO EXTRA SMOOTH SUN PROTECTION N
octinoxate, octocrylene, and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-348 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2766 mg in 56.45 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1694 mg in 56.45 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 7056 mg in 56.45 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISODODECANE (UNII: A8289P68Y2) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CYCLOMETHICONE (UNII: NMQ347994Z) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) XYLITOL (UNII: VCQ006KQ1E) METHYL GLUCETH-10 (UNII: N0MWT4C7WH) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) ONONIS SPINOSA ROOT (UNII: FD2FMC53M1) ECTOINE (UNII: 7GXZ3858RY) HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7) ISOSTEARIC ACID (UNII: X33R8U0062) EDETATE TRISODIUM (UNII: 420IP921MB) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL) ALUMINUM OXIDE (UNII: LMI26O6933) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) PHENOXYETHANOL (UNII: HIE492ZZ3T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-348-60 1 in 1 CARTON 02/01/2013 1 56.45 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 02/01/2013 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICA INC. 782677132 MANUFACTURE(58411-348) , ANALYSIS(58411-348)
