Label: CITY SUNSCREEN SERUM BROAD SPECTRUM SPF 30 SUPERGOOP- homosalate, octisalate, avobenzene, octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 75936-221-01 - Packager: Taylor James, Ltd.
- Category: HUMAN OTC DRUG LABEL
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 February 7, 2017
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
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: 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 sunscreenwith Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
Limit time in the sun,especially from 10 a.m. -2p.m.
Wear long-sleeved shirts, pants, hats, and sunglasses
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INACTIVE INGREDIENT
Inactive Ingredients Purified water (Aqua), Cyclometicone, Isostearyl Neopentanoate, Glycerin, Ceteareth-20, Polypropylene, Cetearyl Alcohol, Xanthan Gum, d-Panthenol, Octanohydroxamic acid, Caprylyl Glycol, Silica, Triacontanyl PVP, Cetyl Dimethicone, Ammonium Acryloyldimethyltaurate/VP Copolymer, PEG-40 Stearate, Tocopheryl, Disodium EDTA, Pentylene Glycol, Pantheyl Triacetate, Sodium Lactate, Lactic Acid, Serine, Urea, Sorbitol, Sodium Chloride, Allantoin, Oleyl Alcohol, Ethyl Linoleate.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CITY SUNSCREEN SERUM BROAD SPECTRUM SPF 30 SUPERGOOP
homosalate, octisalate, avobenzene, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-221 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 8 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2 g in 100 mL Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE (UNII: NMQ347994Z) GLYCERIN (UNII: PDC6A3C0OX) XANTHAN GUM (UNII: TTV12P4NEE) PANTHENOL (UNII: WV9CM0O67Z) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I) EDETATE DISODIUM (UNII: 7FLD91C86K) PENTYLENE GLYCOL (UNII: 50C1307PZG) SODIUM LACTATE (UNII: TU7HW0W0QT) LACTIC ACID (UNII: 33X04XA5AT) SERINE (UNII: 452VLY9402) UREA (UNII: 8W8T17847W) SORBITOL (UNII: 506T60A25R) SODIUM CHLORIDE (UNII: 451W47IQ8X) ALLANTOIN (UNII: 344S277G0Z) OLEYL ALCOHOL (UNII: 172F2WN8DV) ETHYL LINOLEATE (UNII: MJ2YTT4J8M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-221-01 3 mL in 1 PACKET; Type 0: Not a Combination Product 12/07/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/07/2010 Labeler - Taylor James, Ltd. (033381850) Registrant - Le Papillon, Ltd. (040070823) Establishment Name Address ID/FEI Business Operations Le Papillon, Ltd. 040070823 label(75936-221) Establishment Name Address ID/FEI Business Operations Baxter Laboratories 740537709 manufacture(75936-221)