FDA.reportPublic FDA data

Naked Skin One and Done, Medium Dark

Manufacturer
Autumn Harp Inc.
Effective date
2019-09-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:09:55

Label at a glance#

ProductNaked Skin One and Done, Medium Dark
Active ingredientZINC OXIDE, OCTINOXATE
Label structure10 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

For sunscreen use: Apply liberally 15 minutes before sun exposer. 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...

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%

Zinc Oxide 3.4%

PURPOSE:

OTC - PURPOSE SECTION

Sunscreen

USES:

INDICATIONS & USAGE SECTION

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.

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

OTC - WHEN USING SECTION

For sunscreen use: Apply liberally 15 minutes before sun exposer. 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:

OTHER SAFETY INFORMATION

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Water, Isododecane, Cyclopentasiloxane, Adipic Acid / Neopentyl Glycol Crosspolymer, Lauryl Dimethicone, Aloe Barbadensis Leaf Juice, Titanium Dioxide, Polyglyceryl-6 Polyricinoleate, Dimethicone/Vinyl Dimethicone Crosspolymer, Isononyl Isononanoate, Propylene Glycol, Hydrogenated Polyisobutene, Iron Oxide (CI 77492), Polyglyceryl-2 Isostearate, Glycerin, Phenoxyethanol, Propanediol, Dimethicone Crosspolymer, Disteardimonium Hectorite, Isopropyl Myristate, Sodium Chloride, Glycyrrhiza Glabra (Licorice) Root Extract, Iron Oxides (CI 77491), Aspergillus Ferment, Xanthan Gum, Isoceteth-10, Iron Oxides (CI 77499), Silica, Isopropyl Titanium Triisostearate, Stearalkonium Hectorite, Triethoxycaprylylsilane, Evodia Rutaecarpa Fruit Extract, Ethoxydiglycol, Cyclotetrasiloxane, Propylene Carbonate, Dimethylcyclosiloxane, Polyhydroxystearic Acid, BHT, Sorbic Acid.

Questions or comments?

OTC - QUESTIONS SECTION

CALL TOLL FREE

1-800-784-8722(URBAN)

Principle Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton LabelCarton LabelTube LabelTube LabelImage Content

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51514-0346-02021-01-29C16284748780-1ba0f9c33-5b41-a910-e053-dadaa90a0b85Naked Skin One and Done, Medium Dark

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51514-034651514-0346-0

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
ISODODECANEA8289P68Y2IACT
LAURYL TRISILOXANE5OHO78HI1DIACT
OCTINOXATE4Y5P7MUD51ACTIB
FERROSOFERRIC OXIDEXM0M87F357IACT
SODIUM CHLORIDE451W47IQ8XIACT
XANTHAN GUMTTV12P4NEEIACT
ISOPROPYL TITANIUM TRIISOSTEARATE949E3KBJ1IIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
PROPYLENE CARBONATE8D08K3S51EIACT
ALOE VERA LEAFZY81Z83H0XIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
SORBIC ACIDX045WJ989BIACT
POLYGLYCERYL-2 MONOISOSTEARATE7B8OE71MQCIACT
WATER059QF0KO0RIACT
ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S)R9TPS68K19IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
TETRADIUM RUTICARPUM FRUITQ413WWJ3X9IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
CYCLOMETHICONE 50THT5PCI0RIACT
CYCLOMETHICONE 4CZ227117JEIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERRIC OXIDE RED1K09F3G675IACT
HYDROGENATED POLYBUTENE (1300 MW)7D1YQ9Y5EZIACT
PROPANEDIOL5965N8W85TIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
ASPERGILLUS FUMIGATUSX88DF51T48IACT
ISOCETETH-101K92T9919HIACT
STEARALKONIUM HECTORITEOLX698AH5PIACT
DIETHYLENE GLYCOL MONOETHYL ETHER ACETATEW5EIM81UBXIACT

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
935423fe-ae55-8b47-e053-2995a90ae2623460ef52-93b7-2f0c-e054-00144ff8d46c2019-09-24WarningsExact identifier
spl id: 935423fe-ae55-8b47-e053-2995a90ae262
spl set id: 3460ef52-93b7-2f0c-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.