Label: NAKED ONE AND DONE CREAM LIGHT- spf cream cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51514-0343-1 - Packager: Autumn Harp Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated September 26, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DRUG FACTS:
- Active Ingredients
- 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.
- Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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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:
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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, Propylene Glycol, Isononyl Isononanoate, Hydrogenated Polyisobutene, Polyglyceryl-2 Isostearate, Glycerin, Phenoxyethanol, Propanediol, Dimethicone Crosspolymer, Disteardimonium Hectorite, Isopropyl Myristate, Iron Oxide (CI 77492), Sodium Chloride, Glycyrrhiza Glabra (Licorice) Root Extract, Aspergillus Ferment, Xanthan Gum, Isoceteth-10, Silica, Iron Oxides (CI 77491), Isopropyl Titanium Triisostearate, Triethoxycaprylylsilane, Stearalkonium Hectorite, Evodia Rutaecarpa Fruit Extract, Ethoxydiglycol, Cyclotetrasiloxane, Dimethylcyclosiloxane, Iron Oxides (CI 77499), Propylene Carbonate, Polyhydroxystearic Acid, BHT, Sorbic Acid, may contain: titanium dioxide, iron oxides
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NAKED ONE AND DONE CREAM LIGHT
spf cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51514-0343 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.49 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 3.43 g in 100 g Inactive Ingredients Ingredient Name Strength PHENOXYETHANOL (UNII: HIE492ZZ3T) PROPANEDIOL (UNII: 5965N8W85T) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) CYCLOMETHICONE 4 (UNII: CZ227117JE) PROPYLENE CARBONATE (UNII: 8D08K3S51E) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) POLYGLYCERYL-2 MONOISOSTEARATE (UNII: 7B8OE71MQC) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) XANTHAN GUM (UNII: TTV12P4NEE) ISOCETETH-10 (UNII: 1K92T9919H) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FERRIC OXIDE RED (UNII: 1K09F3G675) STEARALKONIUM HECTORITE (UNII: OLX698AH5P) TETRADIUM RUTICARPUM FRUIT (UNII: Q413WWJ3X9) DIMETHICONE (UNII: 92RU3N3Y1O) SORBIC ACID (UNII: X045WJ989B) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) ISODODECANE (UNII: A8289P68Y2) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19) WATER (UNII: 059QF0KO0R) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ALOE VERA LEAF (UNII: ZY81Z83H0X) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51514-0343-1 1 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) Registrant - Autumn Harp Inc. (064187883) Establishment Name Address ID/FEI Business Operations Autumn Harp Inc. 064187883 manufacture(51514-0343)
