RODAN AND FIELDS REVERSE 4 BROAD SPECTRUM SPF 50 PLUS SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene cream

RODAN AND FIELDS REVERSE 4 BROAD SPECTRUM SPF 50 PLUS SUNSCREEN by

Drug Labeling and Warnings

RODAN AND FIELDS REVERSE 4 BROAD SPECTRUM SPF 50 PLUS SUNSCREEN 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 AND FIELDS REVERSE 4 BROAD SPECTRUM SPF 50+ SUNSCREEN

Active ingredients

Avobenzone 3 %
Homosalate 10%
Octisalate 5%
Octocrylene 2.6%

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 a dime-sized amount evenly over entire face, avoiding the eye area.  Use every morning and apply liberally 15 minutes before sun exposure.
• 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, Dipropylene Glycol, Caprylyl Methicone, Dicaprylyl Carbonate, PEG/PPG-17/6 Copolymer, Potassium Cetyl Phosphate, Methyl Glucose Sesquistearate, Hydrogenated Palm Glycerides, Polyacrylate-15, Polyacrylate-17, Alcohol, Butylene Glycol, Adenosine, Dunaliella Salina Extract, Euterpa Olearacea (Acai) Fruit Extract, Portulaca Olearacea Extract, Morus Alba (Mulberry) Extract, Camellia Sinensis (Green Tea) Leaf Extract, Dipotassium Glycyrrhizate, Panthenol, Tocopheryl Acetate, Caprylyl Glycol, Glyceryl Stearate, Hydrogenated Polydecene, PEG-100 Stearate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80, Cetyl Alcohol, PEG-10 Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Potassium Hydroxide, Disodium EDTA, Fragrance

Other information

Protect this product from excessive heat and direct sun.

SPL UNCLASSIFIED SECTION

Step 4 in the REVERSE Regimen for Brown Spots, Dullness and Sun Damage.  Advanced formula prevents future discoloration by shielding pigment-stimulating UV rays.  Contains SHIELD rf sunscreen technology, an exclusive complex of stabilized avobenzone (a key UVA blocker) and colorless carotenoids (free radical fighting antioxidants) to visibly decelerate the signs of photoaging that appear over time.  Antioxidants vitamin E and green tea provide additional protection from free radicals, while licorice extract and mulberry help to brighten dull skin.  Use as part of the REVERSE Regimen for best results.

Developed by Stanford trained dermatologists Dr. Katie Rodan and Dr. Kathy Fields.  visit rodanandfields.com   Manufactured for Rodan and Fields, LLC   11 Maiden Lane, Suite 400, San Francisco, CA 94108.  Made in the USA  Please Recycle.

QUESTIONS OR COMMENTS

1-888-995-5656

PRINCIPAL DISPLAY PANEL

RODAN + FIELDS  REVERSE 4 Broad Spectrum SPF 50+ Sunscreen RODAN + FIELDS DERMATOLOGISTS   50 mL / 1.7 Fl.Oz.

RODAN AND FIELDS REVERSE 4 BROAD SPECTRUM SPF 50+ SUNSCREEN 50ml (

14222-0420-1)

INGREDIENTS AND APPEARANCE

RODAN AND FIELDS REVERSE 4 BROAD SPECTRUM SPF 50 PLUS SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14222-0420
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	26 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
PEG/PPG-17/6 COPOLYMER (UNII: P5QZM4T259)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ADENOSINE (UNII: K72T3FS567)
DUNALIELLA SALINA (UNII: F4O1DKI9A6)
ACAI (UNII: 46AM2VJ0AW)
PURSLANE (UNII: M6S840WXG5)
WHITE MULBERRY (UNII: MN25R0HH5A)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
ISOHEXADECANE (UNII: 918X1OUF1E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CETYL ALCOHOL (UNII: 936JST6JCN)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14222-0420-1	1 in 1 CARTON	12/19/2017
1		50 mL in 1 TUBE; 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	11/16/2012

Labeler - Rodan & Fields (051659584)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab, Inc.		080366903	manufacture(14222-0420)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab Korea Co., Ltd.		690104005	manufacture(14222-0420)