URBAN DECAY NAKED SKIN ONE AND DONE HYBRID COMPLEXION PERFECTOR BROAD SPECTRUM SPF 20- octinoxate and zinc oxide lotion

Urban Decay Naked Skin One and Done Hybrid Complexion Perfector Broad Spectrum SPF 20 by

Drug Labeling and Warnings

Urban Decay Naked Skin One and Done Hybrid Complexion Perfector Broad Spectrum SPF 20 by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Autumn Harp, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Octinoxate 7.5%

Zinc oxide 3.4%

Purpose

Sunscreen

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

For external use only

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

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

protect the product in this container from excessive heat and direct sun

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?

Call toll free 1-800-784-URBAN (8722)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

URBAN DECAY NAKED SKIN ONE AND DONE HYBRID COMPLEXION PERFECTOR BROAD SPECTRUM SPF 20 
octinoxate and zinc oxide lotion

Product 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)