NAKED SKIN ONE AND DONE, MEDIUM- spf cream cream

Naked Skin One and Done, Medium by

Drug Labeling and Warnings

Naked Skin One and Done, Medium by is a Otc medication manufactured, distributed, or labeled by Autumn Harp Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS:

Active Ingredients:

Octinoxate 7.5%

Zinc Oxide 3.4%

PURPOSE:

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

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

Directions:

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:

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

Inactive Ingredients:

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?

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1-800-784-8722(URBAN)

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INGREDIENTS AND APPEARANCE

NAKED SKIN ONE AND DONE, MEDIUM 
spf cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51514-0345
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 4 (UNII: CZ227117JE)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48)
XANTHAN GUM (UNII: TTV12P4NEE)
ISOCETETH-10 (UNII: 1K92T9919H)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIETHYLENE GLYCOL MONOETHYL ETHER ACETATE (UNII: W5EIM81UBX)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SORBIC ACID (UNII: X045WJ989B)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
FERRIC OXIDE RED (UNII: 1K09F3G675)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TETRADIUM RUTICARPUM FRUIT (UNII: Q413WWJ3X9)
WATER (UNII: 059QF0KO0R)
ISODODECANE (UNII: A8289P68Y2)
ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19)
LAURYL TRISILOXANE (UNII: 5OHO78HI1D)
PROPANEDIOL (UNII: 5965N8W85T)
POLYGLYCERYL-2 MONOISOSTEARATE (UNII: 7B8OE71MQC)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51514-0345-0	40 g in 1 TUBE; Type 0: Not a Combination Product	02/04/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/04/2016

Labeler - Autumn Harp Inc. (064187883)

Establishment
Name	Address	ID/FEI	Business Operations
Autumn Harp Inc.		064187883	manufacture(51514-0345)