Label: CITY SKIN AGE DEFENSE BROAD SPECTRUM SPF 50- titanium dioxide and zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 70381-119-01, 70381-119-02 - Packager: Murad, LLC
- 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 November 24, 2021
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 ingredients
- Purpose
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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
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
- children under 6 months of age: ask a doctor
- 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 value 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-sleeved shirts, pants, hats, and sunglasses.
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Inactive ingredients
Water (Aqua), Dimethicone, C12-15 Alkyl Benzoate, Glycerin, Triheptanoin, Caprylic/Capric Triglyceride, C13-16 Isoparaffin, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Polyurethane-35, Polyhydroxystearic Acid, Polymethylsilsesquioxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Avena Sativa (Oat) Kernel Extract, Xanthophylls, Retinyl Palmitate, Ascorbic Acid, Bisabolol, Hydrolyzed Jojoba Esters, Urea, Yeast Amino Acids, Trehalose, Inositol, Taurine, Betaine, Tocopherol, Biosaccharide Gum-4, Hydroxyphenyl Propamidobenzoic Acid, Silica, Carthamus Tinctorius (Safflower) Seed Oil, Pentylene Glycol, Butylene Glycol, Dimethicone/PEG-10/15 Crosspolymer, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, PEG-8 Dimethicone, Octyldodecanol, Sodium Propoxyhydroxypropyl Thiosulfate Silica, PEG/PPG-18/18 Dimethicone, Triethoxycaprylylsilane, Aluminum Stearate, Alumina, Ethylhexylglycerin, Leuconostoc/Radish Root Ferment Filtrate, Methylpropanediol, Dipropylene Glycol, Caprylyl Glycol, Phenylpropanol, Phenoxyethanol, Potassium Sorbate, Iron Oxides (CI 77491)
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
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INGREDIENTS AND APPEARANCE
CITY SKIN AGE DEFENSE BROAD SPECTRUM SPF 50
titanium dioxide and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70381-119 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.7 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 10 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) GLYCERIN (UNII: PDC6A3C0OX) TRIHEPTANOIN (UNII: 2P6O7CFW5K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) C13-16 ISOPARAFFIN (UNII: LED42LZG6O) ARGAN OIL (UNII: 4V59G5UW9X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POLYURETHANE-35 (NOT MORE THAN 500 MPA.S AT 40%) (UNII: Q2LKX89BE0) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) OAT (UNII: Z6J799EAJK) LUTEIN (UNII: X72A60C9MT) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) ASCORBIC ACID (UNII: PQ6CK8PD0R) .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC) HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W) UREA (UNII: 8W8T17847W) AMINO ACIDS, SOURCE UNSPECIFIED (UNII: 0O72R8RF8A) TREHALOSE (UNII: B8WCK70T7I) INOSITOL (UNII: 4L6452S749) TAURINE (UNII: 1EQV5MLY3D) BETAINE (UNII: 3SCV180C9W) TOCOPHEROL (UNII: R0ZB2556P8) BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90) HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SAFFLOWER OIL (UNII: 65UEH262IS) PENTYLENE GLYCOL (UNII: 50C1307PZG) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) PEG-8 DIMETHICONE (UNII: GIA7T764OD) OCTYLDODECANOL (UNII: 461N1O614Y) SODIUM PROPOXYHYDROXYPROPYL THIOSULFATE SILICA (UNII: 208G222332) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALUMINUM STEARATE (UNII: U6XF9NP8HM) ALUMINUM OXIDE (UNII: LMI26O6933) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) METHYLPROPANEDIOL (UNII: N8F53B3R4R) DIPROPYLENE GLYCOL (UNII: E107L85C40) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHENYLPROPANOL (UNII: 0F897O3O4M) PHENOXYETHANOL (UNII: HIE492ZZ3T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) FERRIC OXIDE RED (UNII: 1K09F3G675) Product Characteristics Color PINK (Light Pink) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70381-119-02 1 in 1 CARTON 11/22/2021 1 NDC:70381-119-01 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 11/22/2021 Labeler - Murad, LLC (781254792) Establishment Name Address ID/FEI Business Operations Cosway Company, Inc. 052400223 MANUFACTURE(70381-119)
