NAKED SKIN ONE AND DONE DEEP- spf cream cream 
Autumn Harp Inc

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.

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Naked Skin One and Done Deep

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.

Keeo 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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NAKED SKIN ONE AND DONE DEEP 
spf cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0348
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51514-0348-040 g in 1 TUBE; Type 0: Not a Combination Product02/04/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/04/2016
Labeler - Autumn Harp Inc (064187883)
Establishment
NameAddressID/FEIBusiness Operations
Autumn Harp Inc.064187883manufacture(51514-0348)

Revised: 9/2019
Document Id: 9379640f-9afb-6263-e053-2995a90a41f0
Set id: 34654cec-f0b6-1d9a-e054-00144ff8d46c
Version: 2
Effective Time: 20190926
 
Autumn Harp Inc