Boxed warning
For external use only
Urban Decay Naked Skin Dark Beauty Balm SPF20
- Manufacturer
- Autumn Harp, Inc.
- Effective date
- 2014-01-27
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:37:32
Label at a glance#
ProductUrban Decay Naked Skin Dark Beauty Balm SPF20
Active ingredientOCTINOXATE, ZINC OXIDE
Label structure14 sections
Indications and 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.
Dosage and administration
• 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, esp...
Label contents#
Full prescribing information#
WARNINGS AND PRECAUTIONS SECTION
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
SAFE HANDLING WARNING SECTION
Do not use on damaged or broken skin.
WARNINGS AND PRECAUTIONS SECTION
When using this product keep out of eyes • Rinse with water to remove.
WARNINGS SECTION
Stop use and ask a doctor if rash occurs.
USER SAFETY WARNINGS SECTION
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 Components
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 51514-0333-1 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-4cdd-60a7-e053-dbdaa90a05bd | Urban Decay Naked Skin Dark Beauty Balm SPF20 |
| 51514-0333-2 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-4cdd-60a7-e053-dbdaa90a05bd | Urban Decay Naked Skin Dark Beauty Balm SPF20 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51514-0333 | URBAN DECAY NAKED SKIN DARK BEAUTY BALM SPF20 (OCTINOXATE, ZINC OXIDE) LOTION [AUTUMN HARP, INC.] | 1 | Legacy NDC | 20140130_ce9746a4-2b95-495d-af27-02a94d6b0af3.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| ZINC OXIDE | ACTIVE INGREDIENT | SOI2LOH54Z | 1 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| ZINC CATION | ACTIVE MOIETY | 13S1S8SF37 | 1 | |
| .BETA.-CITRONELLOL, (R)- | INACTIVE INGREDIENT | P01OUT964K | 1 | |
| ADIPIC ACID | INACTIVE INGREDIENT | 76A0JE0FKJ | 1 | |
| ASPARTIC ACID | INACTIVE INGREDIENT | 30KYC7MIAI | 1 | |
| Baicalin | INACTIVE INGREDIENT | 347Q89U4M5 | 1 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | 1 | |
| CITRAL | INACTIVE INGREDIENT | T7EU0O9VPP | 1 | |
| CITRULLINE | INACTIVE INGREDIENT | 29VT07BGDA | 1 | |
| COUMARIN | INACTIVE INGREDIENT | A4VZ22K1WT | 1 | |
| CYCLOMETHICONE 5 | INACTIVE INGREDIENT | 0THT5PCI0R | 1 | |
| DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER | INACTIVE INGREDIENT | RSA9I561OK | 1 | |
| DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) | INACTIVE INGREDIENT | 9E4CO0W6C5 | 1 | |
| Disteardimonium Hectorite | INACTIVE INGREDIENT | X687XDK09L | 1 | |
| EUGENOL | INACTIVE INGREDIENT | 3T8H1794QW | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | 1 | |
| GERANIOL | INACTIVE INGREDIENT | L837108USY | 1 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| HYDROGENATED POLYBUTENE (1300 MW) | INACTIVE INGREDIENT | 7D1YQ9Y5EZ | 1 | |
| Isoceteth-10 | INACTIVE INGREDIENT | 1K92T9919H | 1 | |
| Isododecane | INACTIVE INGREDIENT | A8289P68Y2 | 1 | |
| Isononyl Isononanoate | INACTIVE INGREDIENT | S4V5BS6GCX | 1 | |
| Isopropyl Myristate | INACTIVE INGREDIENT | 0RE8K4LNJS | 1 | |
| Isopropyl Titanium Triisostearate | INACTIVE INGREDIENT | 949E3KBJ1I | 1 | |
| LAURETH-7 | INACTIVE INGREDIENT | Z95S6G8201 | 1 | |
| LAURYL PEG/PPG-18/18 METHICONE | INACTIVE INGREDIENT | ZJ5S27D9NX | 1 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | 1 | |
| LIMONENE, (+/-)- | INACTIVE INGREDIENT | 9MC3I34447 | 1 | |
| LINALOOL, (+/-)- | INACTIVE INGREDIENT | D81QY6I88E | 1 | |
| LYSINE HYDROCHLORIDE | INACTIVE INGREDIENT | JNJ23Q2COM | 1 | |
| NEOPENTYL GLYCOL | INACTIVE INGREDIENT | QI80HXD6S5 | 1 | |
| PEG/PPG-18/18 Dimethicone | INACTIVE INGREDIENT | 9H0AO7T794 | 1 | |
| Phenoxyethanol | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| POLYHYDROXYSTEARIC ACID (2300 MW) | INACTIVE INGREDIENT | YXH47AOU0F | 1 | |
| Propanediol | INACTIVE INGREDIENT | 5965N8W85T | 1 | |
| Propylene Carbonate | INACTIVE INGREDIENT | 8D08K3S51E | 1 | |
| ROSEMARY | INACTIVE INGREDIENT | IJ67X351P9 | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| Sodium Chloride | INACTIVE INGREDIENT | 451W47IQ8X | 1 | |
| Stearalkonium Hectorite | INACTIVE INGREDIENT | OLX698AH5P | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| Triethoxycaprylylsilane | INACTIVE INGREDIENT | LDC331P08E | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| watermelon | INACTIVE INGREDIENT | 231473QB6R | 1 | |
| Xanthan Gum | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Products#
Every source-derived product name is available through these pages.
- Urban Decay Naked Skin Dark Beauty Balm SPF20
- Octinoxate, Zinc Oxide
- OCTINOXATE
- ZINC OXIDE
- ZINC CATION
- CYCLOMETHICONE 5
- WATER
- Isododecane
- ADIPIC ACID
- NEOPENTYL GLYCOL
- LAURETH-7
- DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
- LAURYL PEG/PPG-18/18 METHICONE
- HYDROGENATED POLYBUTENE (1300 MW)
- Glycerin
- Propanediol
- DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER
- Phenoxyethanol
- FERRIC OXIDE YELLOW
- Disteardimonium Hectorite
- Isononyl Isononanoate
- Sodium Chloride
- TITANIUM DIOXIDE
- PEG/PPG-18/18 Dimethicone
- Xanthan Gum
- Isopropyl Myristate
- Propylene Carbonate
- FERRIC OXIDE RED
- Isoceteth-10
- FERROSOFERRIC OXIDE
- SILICON DIOXIDE
- LYSINE HYDROCHLORIDE
- ROSEMARY
- LECITHIN, SOYBEAN
- watermelon
- Triethoxycaprylylsilane
- Isopropyl Titanium Triisostearate
- Stearalkonium Hectorite
- POLYHYDROXYSTEARIC ACID (2300 MW)
- CITRULLINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 51514-0333 | 51514-0333-1, 51514-0333-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Isopropyl Myristate | ISOPROPYL MYRISTATE | 0RE8K4LNJS | CREAM / VAGINAL | 50 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | DROPS / ORAL | 300 mg/1ml | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CAPSULE, LIQUID FILLED / ORAL | 0.1 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | TABLET, CHEWABLE / ORAL | 20 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | FILM / BUCCAL | 0.27 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | LOZENGE / ORAL | 120 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | GRANULE, FOR SUSPENSION / ORAL | 162 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SPRAY / NASAL | 22.3 mg/1ml | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, EMULSION / INTRAVENOUS | 24100 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SYSTEM / TOPICAL | 18144 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRAVENOUS | 28773 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 24 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / EPIDURAL | 648 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / OPHTHALMIC | 10 mg | ||
| CYCLOMETHICONE 5 | CYCLOMETHICONE 5 | 0THT5PCI0R | AEROSOL / TOPICAL | 2.5 %w/w | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | SOLUTION / OPHTHALMIC | 0.6 %w/v | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / AURICULAR (OTIC) | 18 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | POWDER / RESPIRATORY (INHALATION) | NA | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRACAUDAL | 210 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | POWDER / ORAL | 275 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / ENDOTRACHEAL | 68 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | TABLET / ORAL | 231 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | TABLET, CHEWABLE / ORAL | 12 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / VAGINAL | 227.9 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / INTRAVENOUS | 90 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET / SUBLINGUAL | 1 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / INTRACAUDAL | 210 mg | ||
| Isopropyl Myristate | ISOPROPYL MYRISTATE | 0RE8K4LNJS | AEROSOL / TOPICAL | 9.3 %w/w | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, DELAYED RELEASE / ORAL | 14 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | DROPS / OPHTHALMIC | 0.08 %w/w | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / INTRAVESICAL | 351 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SHAMPOO, SUSPENSION / TOPICAL | 3 %w/v | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | LIQUID / NASAL | 7.4 mg/1ml | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, COATED / ORAL | 0.01 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | SUSPENSION / RECTAL | 452 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, SOLUBLE / ORAL | 2 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUS | NA | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SPRAY, METERED / NASAL | 13 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRADERMAL | 7 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SYRUP / ORAL | 40 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SHAMPOO / TOPICAL | 150 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE / ORAL | 1190 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | NA | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | SUSPENSION, EXTENDED RELEASE / ORAL | 2.7 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / SUBMUCOSAL | 16 %w/v | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | CREAM / VAGINAL | 1 %w/w | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | JELLY / NASAL | NA | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | ENEMA / RECTAL | 0.7 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | DOUCHE / VAGINAL | 1 %w/w | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION/ DROPS / OPHTHALMIC | 55 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | LOTION / TOPICAL | 0.3 %w/v | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | GEL, METERED / TOPICAL | 4 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / OPHTHALMIC | 2.5 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | JELLY / TOPICAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / VAGINAL | 8 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED / ORAL | 3 mg |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 3be87ace-b30b-4b05-b4d8-fd4aa4f0eb8d | ce9746a4-2b95-495d-af27-02a94d6b0af3 | 2014-01-27 | Boxed warning, Warnings | 3be87ace-b30b-4b05-b4d8-fd4aa4f0eb8d ce9746a4-2b95-495d-af27-02a94d6b0af3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.