RODAN AND FIELDS ESSENTIALS UVA/UVB- avobenzone, octinoxate, oxybenzone cream

Rodan and Fields by

Drug Labeling and Warnings

Rodan and Fields by is a Otc medication manufactured, distributed, or labeled by Cosmetic Enterprises Ltd., Rodan & Fields, LLC., Cosmetic Enterprises Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Questions or Comments

1-888-895-5656

Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.

PRINCIPAL DISPLAY PANEL

Essential UVA/UVB SPF 15

1.7 fl.oz./50 ml

INGREDIENTS AND APPEARANCE

RODAN AND FIELDS  ESSENTIALS UVA/UVB
avobenzone, octinoxate, oxybenzone cream

Product 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