Label: NAKED SKIN ONE AND DONE DEEP- spf cream cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51514-0348-0 - 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
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- DRUG FACTS:
- Active Ingredients:
- PURPOSE:
- USES:
- Warnings: For external use only.
- KEEP OUT OF REACH OF CHILDREN
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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, 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.
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INGREDIENTS AND APPEARANCE
NAKED SKIN ONE AND DONE DEEP
spf cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51514-0348 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 ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) ALOE VERA LEAF (UNII: ZY81Z83H0X) POLYGLYCERYL-2 MONOISOSTEARATE (UNII: 7B8OE71MQC) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM CHLORIDE (UNII: 451W47IQ8X) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) WATER (UNII: 059QF0KO0R) ISODODECANE (UNII: A8289P68Y2) LAURYL TRISILOXANE (UNII: 5OHO78HI1D) PROPANEDIOL (UNII: 5965N8W85T) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) STEARALKONIUM HECTORITE (UNII: OLX698AH5P) XANTHAN GUM (UNII: TTV12P4NEE) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) ISOCETETH-10 (UNII: 1K92T9919H) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) PROPYLENE CARBONATE (UNII: 8D08K3S51E) TETRADIUM RUTICARPUM FRUIT (UNII: Q413WWJ3X9) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) SORBIC ACID (UNII: X045WJ989B) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CYCLOMETHICONE 4 (UNII: CZ227117JE) FERRIC OXIDE RED (UNII: 1K09F3G675) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51514-0348-0 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(51514-0348)
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