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![RODAN AND FIELDS ESSENTIALS UVA/UVB (AVOBENZONE, OCTINOXATE, OXYBENZONE) CREAM [COSMETIC ENTERPRISES LTD.]](https://medic.hrt.org//dailymed/images/c732ff03-8777-4431-989d-141ba2eca349/front.jpg)
| NDC | 56152-0815-1, 56152-0815-2 |
| Set ID | c732ff03-8777-4431-989d-141ba2eca349 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Cosmetic Enterprises Ltd. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
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ACTIVE INGREDIENT
Active Ingredients Purpose
Avobenzone 2.0% Sunscreen
Octinoxate 7.5% Sunscreen
Oxybenzone 3.0 % Sunscreen
Warnings
For external use only.
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash or irritation develops and lasts
Keep out of of children. If swallowed, get medical help or contact a Poison Control Center right away.
water (aqua purificata) purified, diisopropyl adipate, cyclopentasiloxane, methylpropanediol, lauryl methacrylate/glycol dimethacrylate crosspolymer, glyceryl stearate, peg-100 stearate, cetearyl alcohol, polyacrylamide, glyceryl dilaurate, ascorbyl palmitate, aluminum starch octenylsuccinate, ceteareth-20, laureth-7, sodium salicylate, c13-14 isoparaffin, fragrance (parfum), phenoxyethanol, methylparaben, propylparaben
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RODAN AND FIELDS ESSENTIALS UVA/UVB
avobenzone, octinoxate, oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:56152-0815 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.0 mL in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mL in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 3.0 mL in 100 mL Inactive Ingredients Ingredient Name Strength DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) METHYLPROPANEDIOL (UNII: N8F53B3R4R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ASCORBYL PALMITATE (UNII: QN83US2B0N) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) LAURETH-7 (UNII: Z95S6G8201) SODIUM SALICYLATE (UNII: WIQ1H85SYP) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:56152-0815-2 1 in 1 BOX 1 NDC:56152-0815-1 30 mL in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/01/2009 Labeler - Cosmetic Enterprises Ltd. (017701475) Registrant - Rodan & Fields, LLC. (051659584) Establishment Name Address ID/FEI Business Operations Cosmetic Enterprises Ltd 017701475 manufacture
