REVERSE LIGHTENING REGIMEN FOR THE APPEARANCE OF STUBBORN DARK MARKS, PATCHES AND AGE SPOTS- hydroquinone, avobenzone, homosalate, octisalate, octocrylene kit

REVERSE Lightening Regimen for the Appearance of Stubborn Dark Marks, Patches and Age Spots by

Drug Labeling and Warnings

REVERSE Lightening Regimen for the Appearance of Stubborn Dark Marks, Patches and Age Spots by is a Otc medication manufactured, distributed, or labeled by Rodan & Fields, LLC. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Broad Spectrum SPF 50+ Sunscreen

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

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

Skin Lightening Treatment

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

Drug Facts

Active Ingredients

Hydroquinone 2%

Purpose

Skin lightener

Uses

For the gradual fading of dark areas such as freckles, age and liver spots, or pigment in the skin that may occur in pregnancy or from the use of oral contraceptives.

Warnings

For external use only

When using this product

• Avoid contact with eyes

Stop use and ask doctor if

• Condition worsens
• Symptoms last more than 7 days or clear up and occur again within a few days

Do not use on

• Deep or puncture wounds
• Animal bites
• Serious burns

Keep out of reach of children.

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

Directions

Apply a thin, even layer over the entire face, avoiding the eye area. Do not rinse off. Use twice daily. Apply as needed.

• Adults: apply a small amount as a thin layer on affected area once or twice daily, or use as directed by a doctor. If no improvement is seen after three months of treatment, use of this product should be discontinued. Lightening effect of this product may not be noticeable when used on very dark skin.
• Sun exposure should be limited by using a sunscreen agent, a sun blocking agent,or protective clothing to cover bleached skin when using and after using the product in order to prevent darkening from reoccurring.
• Children under 12 years of age: do not use unless directed by a doctor.

Inactive Ingredients

Water/Aqua/Eau, Ethoxydiglycol, Cetearyl Alcohol, PPG-12/SMDI Copolymer, Diethylhexyl Sebacate, Polyacrylamide, Ceteareth-20, Glycerin, C13-14 Isoparaffin, Dimethicone, Fragrance/Parfum, Retinol, Ascorbyl Palmitate, Magnesium Ascorbyl Phosphate, Lactic Acid, Arctostaphylos Uva Ursi Leaf Extract, Sodium C14-16 Olefin Sulfonate, Sodium Metabisulfite, Laureth-7, Glyceryl Stearate, PEG-100 Stearate, Tocopheryl Acetate, Citric Acid, Glycine Soja (Soybean) Oil, Propylene Glycol, Disodium EDTA, BHT, Methylparaben, Propylparaben, Benzoic Acid, Sorbic Acid, Chlorphenesin, Imidazolidinyl Urea, Phenoxyethanol, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limonene, Linalool, Yellow 5 (CI 19140), Yellow 6 (CI 15985).

SPL UNCLASSIFIED SECTION

Skin Lightening Toner

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

Drug Facts

Active Ingredients

Hydroquinone 2%

Purpose

Skin lightener

Uses

For the gradual fading of dark areas such as freckles, age and liver spots, or pigment in the skin that may occur in pregnancy or from the use of oral contraceptives.

Warnings

For external use only

When using this product

• Avoid contact with eyes

Stop use and ask doctor if

• Condition worsens
• Symptoms last more than 7 days or clear up and occur again within a few days

Do not use on

• Deep or puncture wounds
• Animal bites
• Serious burns

Keep out of reach of children.

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

Directions

Apply a thin, even layer over the entire face, avoiding the eye area. Do not rinse off. Use twice daily. Apply as needed.

• Adults: apply a small amount as a thin layer on affected area once or twice daily, or use as directed by a doctor. If no improvement is seen after three months of treatment, use of this product should be discontinued. Lightening effect of this product may not be noticeable when used on very dark skin.
• Sun exposure should be limited by using a sunscreen agent, a sun blocking agent,or protective clothing to cover bleached skin when using and after using the product in order to prevent darkening from reoccurring.
• Children under 12 years of age: do not use unless directed by a doctor.

Inactive Ingredients

Water/Aqua/Eau, Ethoxydiglycol, Hamamelis Virginiana (Witch Hazel) Water, Methylpropanediol, Alcohol, Polysorbate 20, Kojic Acid, Salicylic Acid, Magnesium Ascorbyl Phosphate, Arctostaphylos Uva Ursi Leaf Extract, Arnica Montana Flower Extract, Citrus Limon (Lemon) Peel Extract, Foeniculum Vulgare (Fennel) Fruit Extract, Sodium Sulfite, Fragrance/Parfum, PEG-12 Dimethicone, Zinc Phenolsulfonate, Citric Acid, Sodium Metabisulfite, Sodium Hydroxide, Propylene Glycol, Phenoxyethanol, Chlorphenesin, DMDM Hydantoin, Benzoic Acid, Sorbic Acid, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limonene, Linalool, Yellow 5 (CI 19140), Yellow 6 (CI 15985).

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).

Principal Display Panel - Rodan + Fields Reverse Skin Lightening Toner Label

RODAN + FIELDS®
REVERSE

2 Skin Lightening
Toner

Principal Display Panel - Rodan + Fields Reverse Skin Lightening Treatment Label

RODAN + FIELDS®
REVERSE

3 Skin Lightening
Treatment

Principal Display Panel - Rodan + Fields Reverse Broad Spectrum SPF 50+ Sunscreen Label

RODAN + FIELDS®
REVERSE

4 Broad Spectrum
SPF 50+ Sunscreen

Principal Display Panel - Rodan + Fields Reverse Lightening Regimen Carton Label

RODAN + FIELDS®
REVERSE™

Regimen for the Appearance of Stubborn
Dark Marks, Patches and Age Spots

Based on Multi-Med® Therapy, the REVERSE Lightening
Regimen is a complete skincare system that combines
cosmetic and OTC ingredients to gradually lighten stubborn
dark marks, patches and excessive pigmentation. The highly
effective formulas contains 2% Hydroquinone to address
persistent discoloration for a more even, youthful complexion.

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

RODAN + FIELDS®

LIGHTENING

Deep Exfoliating Wash

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

Skin Lightening Toner

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

Skin Lightening Treatment

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

Broad Spectrum
SPF 50+ Sunscreen

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

INGREDIENTS AND APPEARANCE

REVERSE LIGHTENING REGIMEN FOR THE APPEARANCE OF STUBBORN DARK MARKS, PATCHES AND AGE SPOTS 
hydroquinone, avobenzone, homosalate, octisalate, octocrylene kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14222-5030

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14222-5030-1	1 in 1 CARTON; Type 0: Not a Combination Product	06/01/2017

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	50 mL
Part 2	1 BOTTLE	125 mL
Part 3	1 TUBE	50 mL

Part 1 of 3

SKIN LIGHTENING TONER 
hydroquinone lotion

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hydroquinone (UNII: XV74C1N1AE) (Hydroquinone - UNII:XV74C1N1AE)	Hydroquinone	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B)
Hamamelis Virginiana Top Water (UNII: NT00Y05A2V)
Methylpropanediol (UNII: N8F53B3R4R)
Alcohol (UNII: 3K9958V90M)
Polysorbate 20 (UNII: 7T1F30V5YH)
Kojic Acid (UNII: 6K23F1TT52)
Salicylic Acid (UNII: O414PZ4LPZ)
Magnesium Ascorbyl Phosphate (UNII: 0R822556M5)
Arctostaphylos Uva-Ursi Leaf (UNII: 3M5V3D1X36)
Arnica Montana Flower (UNII: OZ0E5Y15PZ)
Lemon Peel (UNII: 72O054U628)
Fennel Seed (UNII: G3QC02NIE6)
Sodium Sulfite (UNII: VTK01UQK3G)
PEG-12 Dimethicone (UNII: ZEL54N6W95)
Zinc Phenolsulfonate (UNII: 4O71YT5YB5)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Sodium Metabisulfite (UNII: 4VON5FNS3C)
Sodium Hydroxide (UNII: 55X04QC32I)
Propylene Glycol (UNII: 6DC9Q167V3)
Phenoxyethanol (UNII: HIE492ZZ3T)
Chlorphenesin (UNII: I670DAL4SZ)
DMDM Hydantoin (UNII: BYR0546TOW)
Benzoic Acid (UNII: 8SKN0B0MIM)
Sorbic Acid (UNII: X045WJ989B)
Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde (UNII: QUE43B9Z2Q)
Limonene, (+)- (UNII: GFD7C86Q1W)
Linalool, (+/-)- (UNII: D81QY6I88E)
FD&C Yellow No. 5 (UNII: I753WB2F1M)
FD&C Yellow No. 6 (UNII: H77VEI93A8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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	part358A	06/01/2017

Part 2 of 3

SKIN LIGHTENING TREATMENT 
hydroquinone liquid

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hydroquinone (UNII: XV74C1N1AE) (Hydroquinone - UNII:XV74C1N1AE)	Hydroquinone	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
PPG-12/SMDI Copolymer (UNII: 1BK9DDD24E)
Diethylhexyl Sebacate (UNII: U9LS47Q72Q)
Polyacrylamide (1500 MW) (UNII: 5D6TC4BRWV)
Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)
Glycerin (UNII: PDC6A3C0OX)
C13-14 Isoparaffin (UNII: E4F12ROE70)
Dimethicone (UNII: 92RU3N3Y1O)
Retinol (UNII: G2SH0XKK91)
Ascorbyl Palmitate (UNII: QN83US2B0N)
Magnesium Ascorbyl Phosphate (UNII: 0R822556M5)
Lactic Acid (UNII: 33X04XA5AT)
Arctostaphylos Uva-Ursi Leaf (UNII: 3M5V3D1X36)
Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)
Sodium Metabisulfite (UNII: 4VON5FNS3C)
Laureth-7 (UNII: Z95S6G8201)
Glyceryl Monostearate (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Soybean Oil (UNII: 241ATL177A)
Propylene Glycol (UNII: 6DC9Q167V3)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)
Benzoic Acid (UNII: 8SKN0B0MIM)
Sorbic Acid (UNII: X045WJ989B)
Chlorphenesin (UNII: I670DAL4SZ)
Imidurea (UNII: M629807ATL)
Phenoxyethanol (UNII: HIE492ZZ3T)
Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde (UNII: QUE43B9Z2Q)
Limonene, (+)- (UNII: GFD7C86Q1W)
Linalool, (+/-)- (UNII: D81QY6I88E)
FD&C Yellow No. 5 (UNII: I753WB2F1M)
FD&C Yellow No. 6 (UNII: H77VEI93A8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		125 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	part358A

Part 3 of 3

BROAD SPECTRUM SPF 50 SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
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		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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/01/2017

Labeler - Rodan & Fields, LLC. (051659584)