NDC | 51514-0319-1, 51514-0319-2 |
Set ID | eb590a2e-21cb-4ab9-ab4c-1aca99c73ed7 |
Category | HUMAN OTC DRUG LABEL |
Packager | Autumn Harp, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- 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, Glycerin, Hydrogenated Polyisobutene, Propanediol, Phenoxyethanol, Dimethicone Crosspolymer, Disteardimonium Hectorite, Isononyl Isononanoate, Sodium Chloride, PEG/PPG-18/18 Dimethicone, Isopropyl Myristate, Xanthan Gum, Propylene Carbonate, Isoceteth-10, Silica, Lysine HCL, Fragrance, Lecithin, Citrullus Lanatus (Watermelon) Fruit Extract, Triethoxycaprylylsilane, Isopropyl Titanium Triisostearate, Stearalkonium Hectorite, Citrulline, Polyhydroxystearic Acid, Biacalin, Linalool, Limonene, Tripeptide-9 Citrulline, Geraniol, Citral, Eugenol, Coumarin, Citronellol. May contain: Cl 77891 (Titanium Dioxide), Cl 77491/77499 (Iron Oxicdes).
- Other Information
- Questions or comments
- Principal Display Panel
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
URBAN DECAY NAKED SKIN BEAUTY BALM SPF 20
octinoxate, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51514-0319 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 WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) 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) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) 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) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) 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 RED (UNII: 1K09F3G675) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM) ROSEMARY (UNII: IJ67X351P9) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) watermelon (UNII: 231473QB6R) Triethoxycaprylylsilane (UNII: LDC331P08E) Isopropyl Titanium Triisostearate (UNII: 949E3KBJ1I) Stearalkonium Hectorite (UNII: OLX698AH5P) FERROSOFERRIC OXIDE (UNII: XM0M87F357) CITRULLINE (UNII: 29VT07BGDA) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) Baicalin (UNII: 347Q89U4M5) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) LINALOOL, (+/-)- (UNII: D81QY6I88E) LIMONENE, (+/-)- (UNII: 9MC3I34447) ASPARTIC ACID (UNII: 30KYC7MIAI) GERANIOL (UNII: L837108USY) CITRAL (UNII: T7EU0O9VPP) EUGENOL (UNII: 3T8H1794QW) COUMARIN (UNII: A4VZ22K1WT) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51514-0319-1 35 mL in 1 TUBE 2 NDC:51514-0319-2 15 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 07/12/2013 Labeler - Autumn Harp, Inc. (064187883) Establishment Name Address ID/FEI Business Operations Autumn Harp, Inc. 064187883 manufacture(51514-0319)