Label: URBAN DECAY NAKED SKIN ILLUMINATING BEAUTY BALM SPF20- octinoxate, zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 51514-0335-1 - Packager: Autumn Harp, Inc.
- 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 25, 2014
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- Official Label (Printer Friendly)
- WARNINGS AND PRECAUTIONS
- Active Ingredient
- Purpose
- Uses
- BOXED WARNING (What is this?)
- SAFE HANDLING WARNING
- WARNINGS AND PRECAUTIONS
- WARNINGS
- USER SAFETY 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
• Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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 10am - 2pm.
• Wear long-sleeve shirts, pants, hats, and sunglasses
• Children under 6 months: Ask a doctor
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Inactive Ingredients
Cyclopentasiloxane, Water, Isododecane, Adipic Acid / Neopentyl Glycol Crosspolymer, Lauryl Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Lauryl PEG/PPG-18/18 Methicone, Mica, Hydrogenated Polyisobutene, Glycerin, Propanediol, Phenoxyethanol, Dimethicone Crosspolymer, Disteardimonium Hectorite, Isononyl Isononanoate, Sodium Chloride, PEG/PPG-18/18 Dimethicone, Xanthan Gum, Isopropyl Myristate, Propylene Carbonate, Isoceteth-10, Isostearyl Alcohol, Propylene Oxide Polymer, Silica, Lysine HCL, Fragrance, Lecithin, Citrullus Lanatus (Watermelon) Fruit Extract, Triethoxycaprylylsilane, Methylalkyl Cyclosiloxanes, Cyclotetrasiloxane, Isopropyl Titanium Triisostearate, Dimethylcyclosiloxane, Stearalkonium Hectorite, Baicalin, Polyhydroxystearic Acid, Citrulline, BHT, Linalool, Limonene, Potassium Sorbate, Sodium Benzoate, Tripeptide-9 Citrulline, Geraniol. May contain: CI77891 (Titanium dioxide), CI77491/77492/77499 (Iron Oxides), CI75470 (Carmine).
- Other Information
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INGREDIENTS AND APPEARANCE
URBAN DECAY NAKED SKIN ILLUMINATING BEAUTY BALM SPF20
octinoxate, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51514-0335 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mg in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 3.4 mg in 100 mL Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) WATER (UNII: 059QF0KO0R) ISODODECANE (UNII: A8289P68Y2) ADIPIC ACID (UNII: 76A0JE0FKJ) NEOPENTYL GLYCOL (UNII: QI80HXD6S5) LAURETH-7 (UNII: Z95S6G8201) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) MICA (UNII: V8A1AW0880) GLYCERIN (UNII: PDC6A3C0OX) PROPANEDIOL (UNII: 5965N8W85T) DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK) PHENOXYETHANOL (UNII: HIE492ZZ3T) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) SODIUM CHLORIDE (UNII: 451W47IQ8X) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) XANTHAN GUM (UNII: TTV12P4NEE) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PROPYLENE CARBONATE (UNII: 8D08K3S51E) ISOCETETH-10 (UNII: 1K92T9919H) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) DODECENE (UNII: WYE669F3GR) PROPYLENE OXIDE (UNII: Y4Y7NYD4BK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FERRIC OXIDE RED (UNII: 1K09F3G675) LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM) ROSEMARY (UNII: IJ67X351P9) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) WATERMELON (UNII: 231473QB6R) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CYCLOMETHICONE 4 (UNII: CZ227117JE) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) STEARALKONIUM HECTORITE (UNII: OLX698AH5P) FERROSOFERRIC OXIDE (UNII: XM0M87F357) CARMINIC ACID (UNII: CID8Z8N95N) BAICALIN (UNII: 347Q89U4M5) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) CITRULLINE (UNII: 29VT07BGDA) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) LINALOOL, (+/-)- (UNII: D81QY6I88E) LIMONENE, (+/-)- (UNII: 9MC3I34447) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) ACV TRIPEPTIDE (UNII: O3VOU3H9VS) GERANIOL (UNII: L837108USY) CITRAL (UNII: T7EU0O9VPP) EUGENOL (UNII: 3T8H1794QW) COUMARIN (UNII: A4VZ22K1WT) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51514-0335-1 35 mL 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 final part352 08/05/2013 Labeler - Autumn Harp, Inc. (064187883) Establishment Name Address ID/FEI Business Operations Autumn Harp, Inc. 064187883 manufacture(51514-0335)
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