URBAN DECAY NAKED SKIN DARK BEAUTY BALM SPF20- octinoxate, zinc oxide lotion 
Autumn Harp, Inc.

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.

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Urban Decay Naked Skin Dark Beauty Balm SPF20

Drug Facts

Active Ingredient

Octinoxate (7.5%)

Zinc Oxide (3.4%)

Purpose

Sunscreen

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

• 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

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

Protect this product from excessive heat and direct sun light.

Questions or comments

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

Principal Display Panel

Image Components15 ml unit carton artwork35 ml unit carton artworkshade label for both 15 ml & 35 ml

URBAN DECAY NAKED SKIN DARK BEAUTY BALM SPF20 
octinoxate, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0333
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mg  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION3.4 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Glycerin (UNII: PDC6A3C0OX)  
Propanediol (UNII: 5965N8W85T)  
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
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)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Isoceteth-10 (UNII: 1K92T9919H)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
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)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
CITRULLINE (UNII: 29VT07BGDA)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51514-0333-135 mL in 1 TUBE
2NDC:51514-0333-215 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/05/2013
Labeler - Autumn Harp, Inc. (064187883)
Establishment
NameAddressID/FEIBusiness Operations
Autumn Harp, Inc.064187883manufacture(51514-0333)

Revised: 1/2014
Document Id: 3be87ace-b30b-4b05-b4d8-fd4aa4f0eb8d
Set id: ce9746a4-2b95-495d-af27-02a94d6b0af3
Version: 1
Effective Time: 20140127
 
Autumn Harp, Inc.