URBAN DECAY NAKED SKIN LIGHT BEAUTY BALM SPF20- octinoxate, zinc oxide lotion

Urban Decay Naked Skin Light Beauty Balm SPF20 by

Drug Labeling and Warnings

Urban Decay Naked Skin Light Beauty Balm SPF20 by is a Otc medication manufactured, distributed, or labeled by Autumn Harp, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS AND PRECAUTIONS

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.

BOXED WARNING

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Warnings

For external use only

SAFE HANDLING WARNING

Do not use on damaged or broken skin.

WARNINGS AND PRECAUTIONS

When using this product keep out of eyes Rinse with water to remove.

WARNINGS

Stop use and ask a doctor if rash occurs.

USER SAFETY WARNINGS

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)

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INGREDIENTS AND APPEARANCE

URBAN DECAY NAKED SKIN LIGHT BEAUTY BALM SPF20 
octinoxate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51514-0331
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51514-0331-1	35 mL in 1 TUBE
2	NDC: 51514-0331-2	15 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/09/2014

Labeler - Autumn Harp, Inc. (064187883)

Establishment
Name	Address	ID/FEI	Business Operations
Autumn Harp, Inc.		064187883	manufacture(51514-0331)