- 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, Propylene Glycol, Isononyl Isononanoate, Hydrogenated Polyisobutene, Polyglyceryl-2 Isostearate, Glycerin, Phenoxyethanol, Propanediol, Dimethicone Crosspolymer, Iron Oxide (CI 77492), Disteardimonium Hectorite, Isopropyl Myristate, Sodium Chloride, Glycyrrhiza Glabra (Licorice) Root Extract, Aspergillus Ferment, Xanthan Gum, Isoceteth-10, Silica, Iron Oxides (CI 77491), Isopropyl Titanium Triisostearate, Stearalkonium Hectorite, Triethoxycaprylylsilane, Iron Oxides (CI 77499), Evodia Rutaecarpa Fruit Extract, Ethoxydiglycol, Cyclotetrasiloxane, Dimethylcyclosiloxane, Propylene Carbonate, Polyhydroxystearic Acid, BHT, Sorbic Acid.
- Questions or comments?
- Principle Display Panel
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INGREDIENTS AND APPEARANCE
NAKED SKIN ONE AND DONE, MEDIUM LIGHT
spf cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51514-0344 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 DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) DIMETHICONE (UNII: 92RU3N3Y1O) PROPYLENE CARBONATE (UNII: 8D08K3S51E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SODIUM CHLORIDE (UNII: 451W47IQ8X) FERRIC OXIDE RED (UNII: 1K09F3G675) STEARALKONIUM HECTORITE (UNII: OLX698AH5P) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) ISODODECANE (UNII: A8289P68Y2) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19) LAURYL TRISILOXANE (UNII: 5OHO78HI1D) WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 4 (UNII: CZ227117JE) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) PROPANEDIOL (UNII: 5965N8W85T) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) XANTHAN GUM (UNII: TTV12P4NEE) ISOCETETH-10 (UNII: 1K92T9919H) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SORBIC ACID (UNII: X045WJ989B) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TETRADIUM RUTICARPUM FRUIT (UNII: Q413WWJ3X9) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51514-0344-1 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(51514-0344)