![RODAN AND FIELDS REDEFINE AM SPF 30 (OCTISALATE, AVOBENZONE, OCTOCRYLENE, HOMOSALATE) CREAM [RODAN AND FIELDS]](https://medic.hrt.org//dailymed/images/3a2c0e7d-a9af-4d83-8339-280df9aa70f9/TripledefenseUC.jpg)
| NDC | 14222-2250-1, 14222-2250-2 |
| Set ID | 3a2c0e7d-a9af-4d83-8339-280df9aa70f9 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Rodan and Fields |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- Active Ingredients
- Purpose
- Uses
- WARNINGS
-
Directions
- Apply a dime-sized amount evenly over entire face every morning and 15 minutes before sun exposure, avoiding the eye area.
- Use a water resistant sunscreen if swimming or sweating
- Reapply at least every 2 hours.
- 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 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-sleeve shirts, pants, hats and sunglasses
- Children under 6 months: Ask a doctor.
-
Inactive ingredients
Water, Isododecane, Ethylhexyl Pamitate, Polymethylsilsesquioxane, Glycerin, Dimethicone, Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Butylene Glycol, Caprylyl Glycol, Sucrose Stearate, Olea Europaea (Olive) Fruit Extract, Hydrogenated Polydecene, Polyurethane-40, Hydrolyzed Silk, Fragrance, Silica, Camellia Oleifera Leaf Extract, Polyacrylate-13, Polyisobutene, Polysorbate-20, Iron Oxides, Tetrapeptide-21, Resveratrol, Phenoxyethanol, Chlorphenesin, Dunaliella Salina Extract, Talc, PEG-12 Dimethicone, Humic Acids, Sodium Hyaluronate
- Other Information
- QUESTIONS
- HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RODAN AND FIELDS REDEFINE AM SPF 30
octisalate, avobenzone, octocrylene, homosalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14222-2250 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5.0 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3.0 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.7 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 2.5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SUCROSE STEARATE (UNII: 274KW0O50M) GLYCERIN (UNII: PDC6A3C0OX) ETHYLHEXYL PALMITATE (UNII: 2865993309) PEG-100 STEARATE (UNII: YD01N1999R) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) CETYL ALCOHOL (UNII: 936JST6JCN) ISODODECANE (UNII: A8289P68Y2) DIMETHICONE (UNII: 92RU3N3Y1O) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) FERRIC OXIDE RED (UNII: 1K09F3G675) TALC (UNII: 7SEV7J4R1U) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) PHENOXYETHANOL (UNII: HIE492ZZ3T) HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7) DUNALIELLA SALINA (UNII: F4O1DKI9A6) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TETRAPEPTIDE-21 (UNII: 179JUC43HU) BOMBYX MORI FIBER (UNII: 6LK42KUV6W) BLACK OLIVE (UNII: 2M6QWV94OC) PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A) CAPRYLYL GLYCOL (UNII: 00YIU5438U) RESVERATROL (UNII: Q369O8926L) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52) POLYSORBATE 20 (UNII: 7T1F30V5YH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14222-2250-2 1 in 1 CARTON 05/01/2013 1 NDC:14222-2250-1 30 mL in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/01/2013 Labeler - Rodan and Fields (051659584)
