RODAN - FIELDS ESSENTIALS BODY SUNSCREEN BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene cream

RODAN - FIELDS ESSENTIALS Body Sunscreen BROAD SPECTRUM SPF 30 by

Drug Labeling and Warnings

RODAN - FIELDS ESSENTIALS Body Sunscreen BROAD SPECTRUM SPF 30 by is a Otc medication manufactured, distributed, or labeled by Rodan & Fields, Englewood Lab, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

RODAN + FIELDS ESSENTIALS Body Sunscreen BROAD SPECTRUM SPF 30

Active ingredients

Avobenzone 2%
Homosalate 7%
Octisalate 4%
Octocrylene 1.7%

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

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure
• Reapply:
• After 40 minutes of swimming or sweating
• Immediately after towel drying
• At least every two hours
• Children under 6 months: Ask a doctor
• 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
  

Inactive ingredients

Water, Dipropylene Glycol, Cyclopentasiloxane, Dimethicone, Polyester-8, Alcohol, VP/Eicosene Copolymer, Caprylyl Glycol, Polyacrylate-15, Potassium Cetyl Phosphate, Glyceryl Stearate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydrogenated Palm Glycerides, Polyacrylate-17, PEG-100 Stearate, Dipotassium Glycyrrhizate, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Cetyl Alcohol, Panthenol, PEG-10 Dimethicone, Methyl Glucose Sesquistearate, Disodium EDTA, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Isohexadecane, Polysorbate 80, Xanthan Gum, Phenoxyethanol, Potassium Hydroxide, Fragrance.

Other information

Protect this product from excessive heat and direct sun.

RODAN - FIELDS ESSENTIALS

This non sticky, non whitening formula contains dimethicone for barrier protection and antioxidants to help counter environmental aggressors.

Manufactured for Rodan and Fields, LLC San Francisco, CA 94105
Made in USA  ESBS150 85-04-0026  Please Recycle  visit  rodanandfields.com

QUESTIONS OR COMMENTS 1-888-995-5656

PRINCIPAL DISPLAY PANEL

RODAN + FIELDS ESSENTIALS  Body Sunscreen BROAD SPECTRUM SPF 30  WATER RESISTANT (40 MINUTES)  RODAN + FIELDS DERMATOLOGISTS  150 mL/5 Fl.Oz.

RODAN + FIELDS ESSENTIALS Body Sunscreen BROAD SPECTRUM SPF 30 150ml (

14222-0001-1)

INGREDIENTS AND APPEARANCE

RODAN - FIELDS ESSENTIALS BODY SUNSCREEN BROAD SPECTRUM SPF 30 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14222-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	40 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	17 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALCOHOL (UNII: 3K9958V90M)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CETYL ALCOHOL (UNII: 936JST6JCN)
PANTHENOL (UNII: WV9CM0O67Z)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ISOHEXADECANE (UNII: 918X1OUF1E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14222-0001-1	1 in 1 CARTON	12/19/2017
1		150 mL in 1 BOTTLE; 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	05/22/2013

Labeler - Rodan & Fields (051659584)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab, Inc.		080366903	manufacture(14222-0001)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab Korea Co., Ltd.		690104005	manufacture(14222-0001)