NDC | 49967-344-01 |
Set ID | b6aa4020-9563-41ec-ac06-9537b6f2c00e |
Category | HUMAN OTC DRUG LABEL |
Packager | L'Oreal USA Products Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
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Directions
For sunscreen use:
● apply liberally 15 minutes before sun exposure
● reapply at least every 2 hours
● use a water resistant sunscreen if swimming or sweating
● 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
● children under 6 months of age: Ask a doctor
- Other information
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Inactive ingredients
water. isododecane, cyclopentasiloxane, adipic acid/neopentyl glycol crosspolymer, lauryl dimethicone, polyglyceryl-6 polyricinoleate, dimethicone/vinyl dimethicone crosspolymer, isononyl isononanoate, propylene glycol, hydrogenated polyisobutene, polyglyceryl-2 isostearate, glycerin, phenoxyethanol, propanediol, isopropyl myristate, dimethicone crosspolymer, disteardimonium hectorite, sodium chloride, glycyrrhiza glabra (licorice) root extract, xanthan gum, silica, isopropyl titanium triisostearate, stearalkonium hectorate, triethoxycaprylylsilane, aspergillus ferment, evodia rutaecarpa fruit extract, isoceteth-10, polyhydroxystearic acid, ethoxydiglycol, propylene carbonate, aloe barbadensis leaf juice powder, BHT, sorbic acid; may contain: titanium dioxide, iron oxides
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
URBAN DECAY NAKED SKIN ONE AND DONE HYBRID COMPLEXION PERFECTOR BROAD SPECTRUM SPF 20
octinoxate and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-344 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 34 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISODODECANE (UNII: A8289P68Y2) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) POLYGLYCERYL-2 MONOISOSTEARATE (UNII: 7B8OE71MQC) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) PROPANEDIOL (UNII: 5965N8W85T) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) XANTHAN GUM (UNII: TTV12P4NEE) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) STEARALKONIUM HECTORITE (UNII: OLX698AH5P) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) TETRADIUM RUTICARPUM FRUIT (UNII: Q413WWJ3X9) ISOCETETH-10 (UNII: 1K92T9919H) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) PROPYLENE CARBONATE (UNII: 8D08K3S51E) ALOE VERA LEAF (UNII: ZY81Z83H0X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SORBIC ACID (UNII: X045WJ989B) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-344-01 1 in 1 CARTON 02/01/2016 1 40 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 not final part352 02/01/2016 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations Autumn Harp, Inc. 064187883 manufacture(49967-344)