REVERSE REGIMEN FOR THE APPEARANCE OF SKIN DULLNESS, DISCOLORATION AND UNEVEN SKIN TONE- avobenzone, homosalate, octisalate, octocrylene lotion

REVERSE Regimen for the Appearance of Skin Dullness, Discoloration and Uneven Skin Tone by

Drug Labeling and Warnings

REVERSE Regimen for the Appearance of Skin Dullness, Discoloration and Uneven Skin Tone by is a Otc medication manufactured, distributed, or labeled by Rodan & Fields. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Broad Spectrum SPF 50+ Sunscreen

SPL UNCLASSIFIED SECTION

50 mL/1.7 Fl. Oz. U.S.

SPL UNCLASSIFIED SECTION

Drug Facts

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 doctor if rash occurs

Keep out of reach of children.

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

Directions

• Apply liberally 15 minutes before sun exposure
• Reapply:
  • at least every 2 hours
  • use a water-resistant sunscreen if swimming or sweating
• 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

Other Information

• Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water/Aqua/Eau, Caprylyl Methicone, Dipropylene Glycol, Dicaprylyl Carbonate, PEG/PPG-17/6 Copolymer, Alcohol Denat., Methyl Glucose Sesquistearate, Potassium Cetyl Phosphate, Dipotassium Glycyrrhizate, Adenosine, Tocopheryl Acetate, Euterpe Oleracea Fruit Extract, Morus Alba Root Extract, Portulaca Oleracea Extract, Camellia Oleifera Leaf Extract, Dunaliella Salina Extract, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyacrylate-15, Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Hydrogenated Palm Glycerides, Fragrance/Parfum, Isohexadecane, Panthenol, Butylene Glycol, PEG-10 Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyacrylate-17, Polysorbate 80, Polydecene, C11-15 Pareth-40, C11-15 Pareth-7, Sorbitan Oleate, Disodium Lauryl Sulfosuccinate, Sodium Laureth-12 Sulfate, Potassium Hydroxide, Disodium EDTA, Tetrasodium EDTA, Phenoxyethanol, Caprylyl Glycol, Citral, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limonene, Linalool.

SPL UNCLASSIFIED SECTION

Deep Exfoliating Wash

125 mL/4.2 Fl. Oz. U.S.

Product Details

Directions

Wet skin with lukewarm water. Using fingertips, gently and evenly massage a thin, even layer over the entire face for 30-60 seconds, avoiding contact with eyes. Rinse thoroughly with water and pat dry. Use once every other day for the first week and increase to twice daily as tolerated.

Warnings

For external use only. When using this product keep out of eyes. Rinse with water to remove. If irritation or rash occurs, discontinue use and consult your doctor. Keep out of reach of children. If product is swallowed, seek medical attention.

Ingredients

Water/Aqua/Eau, C12-15 Alkyl Benzoate, Diethylhexyl Sebacate, Polylactic Acid, Cetearyl Alcohol, Jojoba Esters, PEG-40 Stearate, Glyceryl Stearate, Ammonium Laureth Sulfate, Magnesium Aluminum Silicate, Pentylene Glycol, Potassium Cetyl Phosphate, Ceteareth-20, Hydroxyacetophenone, Lactic Acid, Mentha Piperita (Peppermint) Oil, Fragrance/Parfum, Xanthan Gum, Glycolic Acid, Sodium Magnesium Silicate, Propylene Glycol, Citric Acid, Phenoxyethanol, Potassium Sorbate, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limonene, Linalool, Yellow 5 (CI 19140), Yellow 6 (CI 15985).

SPL UNCLASSIFIED SECTION

Intensive Brightening Toner

125 mL/4.2 Fl. Oz. U.S.

Product Details

Directions

Apply evenly to entire face with a fresh gauze pad, avoiding the eye area. Do not rinse off. Allow to dry. Use morning and evening. Use once every other day for the first week and increase to twice daily as tolerated.

Warnings

For external use only. When using this product keep out of eyes. Rinse with water to remove. If irritation or rash occurs, discontinue use and consult your doctor. Keep out of reach of children. If product is swallowed, seek medical attention.

Ingredients

Water/Aqua/Eau, Hamamelis Virginiana (Witch Hazel) Water, Butylene Glycol, Polysorbate 20, Ethoxydiglycol, Alcohol, Kojic Acid, Dipotassium Glycyrrhizate, Glycyrrhiza Glabra (Licorice) Root Extract, Salicylic Acid, Phenylethyl Resorcinol, Tocopherol, Alanine, Glycine, Isoleucine, Leucine, Fragrance/Parfum, Sodium Sulfite, PEG-12 Dimethicone, Sodium Metabisulfite, Sodium Hydroxide, Citric Acid, Disodium EDTA, Caprylyl Glycol, Chlorphenesin, Phenoxyethanol, Citral, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limonene, Linalool.

SPL UNCLASSIFIED SECTION

Dual Active Brightening Complex

2 x 25 mL/0.85 Fl. Oz. U.S.

Product Details

Directions

After cleansing and toning, dispense an equal pea-sized amount of product from each tube, side by side. Blend product and apply evenly over the entire face, avoiding eye area. Allow product to be absorbed. Do not rinse off. Use once every other day for the first week and increase to twice daily as tolerated.

Warnings

For external use only. When using this product keep out of eyes. Rinse with water to remove. If irritation or rash occurs, discontinue use and consult your doctor. Keep out of reach of children. If product is swallowed, seek medical attention.

Other information

Store between 2-8 ºC (35-47 ºF)

Ingredients

Vitamin C Formula: Isododecane, Cyclopentasiloxane, Cyclohexasiloxane, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Ethoxydiglycol, Ascorbic Acid, Caprylic/Capric Triglyceride, Kojic Acid, Ethylhexyl Hydroxystearate, Polysilicone-11, Syringa Vulgaris (Lilac) Leaf Cell Culture Extract, Maltodextrin.

Retinol Formula: Water/Aqua/Eau, Caprylic/Capric Triglyceride, Butyrospermum Parkii (Shea) Butter, Glycerin, Glyceryl Stearate, Ethoxydiglycol, Butylene Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Stearic Acid, Polysorbate 60, Stearyl Alcohol, Cyclopentasiloxane, Cyclohexasiloxane, Retinol, Dipotassium Glycyrrhizate, Glycyrrhiza Glabra (Licorice) Root Extract, Sodium Hyaluronate, Sorbitol, Tocopheryl Acetate, Fragrance/Parfum, Polysorbate 20, Carbomer, Triethanolamine, Glyceryl Acrylate/Acrylic Acid Copolymer, Caprylyl Glycol, Hexylene Glycol, Ethylhexylglycerin, BHT, Citric Acid, Disodium EDTA, Phenoxyethanol, Methylparaben, Propylparaben, Citral, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limonene, Linalool, Yellow 5 (CI 19140).

Principal Display Panel - Rodan Fields Reverse Carton Label

RODAN + FIELDS®
REVERSE™

Regiment for the Appearance of
Skin Dullness, Discoloration and
Uneven Skin Tone

Based on Multi-Med® Therapy, REVERSE Brightening Regimen is a
complete skincare system that combines cosmetic and OTC
ingredients to visibly brighten and even discolored skin. The
highly effective formulas contain Vitamin C and Retinol to provide
a long-term solution for a more radiant, even complexion.

This 4-step Regimen was developed by Stanford-trained
dermatologists Dr. Katie Rodan and Dr. Kathy Fields.

RODAN + FIELDS®

BRIGHTENING

Deep Exfoliating Wash

125 mL/
4.2 Fl.Oz. U.S.

Intensive Brightening Toner

125 mL/
4.2 Fl.Oz. U.S.

Dual Active Brightening Complex

2 x 25 mL/
0.85 Fl.Oz. U.S.

Broad Spectrum
SPF 50+ Sunscreen

50 mL/
1.7 Fl.Oz. U.S.

Principal Display Panel - Rodan Fields Reverse Tube Label

RODAN + FIELDS®
REVERSE

4 Broad Spectrum
SPF 50 + Sunscreen

INGREDIENTS AND APPEARANCE

REVERSE REGIMEN FOR THE APPEARANCE OF SKIN DULLNESS, DISCOLORATION AND UNEVEN SKIN TONE 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14222-5020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	3.0 g  in 100 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	10 g  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	5 g  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	2.6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Caprylyl Trisiloxane (UNII: Q95M2P1KJL)
Dipropylene Glycol (UNII: E107L85C40)
Dicaprylyl Carbonate (UNII: 609A3V1SUA)
PEG/PPG-17/6 Copolymer (UNII: P5QZM4T259)
Alcohol (UNII: 3K9958V90M)
Methyl Glucose Sesquistearate (UNII: V1YW10H14D)
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)
Adenosine (UNII: K72T3FS567)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Acai (UNII: 46AM2VJ0AW)
Morus Alba Root (UNII: CST1G9BZGD)
Purslane (UNII: M6S840WXG5)
Camellia Oleifera Leaf (UNII: 5077EL0C60)
Dunaliella Salina (UNII: F4O1DKI9A6)
Sodium Acrylate/Sodium Acryloyldimethyltaurate Copolymer (4000000 MW) (UNII: 1DXE3F3OZX)
Cetyl Alcohol (UNII: 936JST6JCN)
Glyceryl Monostearate (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
Hydrogenated Palm Glycerides (UNII: YCZ8EM144Q)
Isohexadecane (UNII: 918X1OUF1E)
Panthenol (UNII: WV9CM0O67Z)
Butylene Glycol (UNII: 3XUS85K0RA)
PEG-10 Dimethicone (600 CST) (UNII: 8PR7V1SVM0)
Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Hydrogenated Polydecene (550 MW) (UNII: U333RI6EB7)
C11-15 Pareth-40 (UNII: L774F88277)
C11-15 Pareth-7 (UNII: 261HPE0IS3)
Sorbitan Monooleate (UNII: 06XEA2VD56)
Disodium Lauryl Sulfosuccinate (UNII: P160Q81342)
Sodium Laureth-12 Sulfate (UNII: 8M492LDU23)
Potassium Hydroxide (UNII: WZH3C48M4T)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
Edetate Sodium (UNII: MP1J8420LU)
Phenoxyethanol (UNII: HIE492ZZ3T)
Caprylyl Glycol (UNII: 00YIU5438U)
Citral (UNII: T7EU0O9VPP)
Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde (UNII: QUE43B9Z2Q)
Limonene, (+)- (UNII: GFD7C86Q1W)
Linalool, (+/-)- (UNII: D81QY6I88E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14222-5020-1	1 in 1 BOX	06/01/2017
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	06/01/2017

Labeler - Rodan & Fields (051659584)