Urban Decay Naked Skin Bronzing Beauty Balm SPF 20

Urban Decay Naked Skin Bronzing Beauty Balm SPF 20 by

Drug Labeling and Warnings

Urban Decay Naked Skin Bronzing Beauty Balm SPF 20 by is a Otc medication manufactured, distributed, or labeled by Autumn Harp, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

URBAN DECAY NAKED SKIN BRONZING BEAUTY BALM SPF 20- 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 Bronzing Beauty Balm SPF 20

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

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 Components

URBAN DECAY NAKED SKIN BRONZING BEAUTY BALM SPF 20 
octinoxate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51514-0334
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 CATION - UNII:13S1S8SF37)	ZINC CATION	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)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
XANTHAN GUM (UNII: TTV12P4NEE)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
ISOCETETH-10 (UNII: 1K92T9919H)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)
ROSEMARY (UNII: IJ67X351P9)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
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)
EUGENOL (UNII: 3T8H1794QW)
COUMARIN (UNII: A4VZ22K1WT)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51514-0334-1	35 mL in 1 TUBE; Type 0: Not a Combination Product	06/27/2013	06/23/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/27/2013	06/23/2014

Labeler - Autumn Harp, Inc. (064187883)

Establishment
Name	Address	ID/FEI	Business Operations
Autumn Harp, Inc.		064187883	manufacture(51514-0334)

Revised: 12/2019

Document Id: 98cf7feb-9943-6fee-e053-2a95a90ad0c8

34390-5

Set id: 5ce401d4-cd4e-4df4-a2b6-c3e68a1567f5

Version: 2

Effective Time: 20191203

 

Autumn Harp, Inc.