RODAN AND FIELDS ENHANCEMENTS LIGHT- titanium dioxide, zinc oxide powder RODAN AND FIELDS ENHANCEMENTS MEDIUM- titanium dioxide, zinc oxide powder RODAN AND FIELDS ENHANCEMENTS BRONZE- titanium dioxide, zinc oxide powder

RODAN and FIELDS ENHANCEMENTS by

Drug Labeling and Warnings

RODAN and FIELDS ENHANCEMENTS by is a Otc medication manufactured, distributed, or labeled by Bentley Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts Active ingredients

Titanium Dioxide 9.6%
Zinc Oxide 4.9%

Purpose

Sunscreen

Keep out of each of children.

Keep out of reach of children.

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

Uses

• Helps prevent sunburn
  

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

Directions

• 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 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

Mica, Polymetylsilsesquioxane, Squalane, Water, Silia, Bismuth Oxychloride, Stearic Acid, Aluminum Hydroxide, Ceramide 3, Cholesterol, Phytosphingosine, Phenoxyethanol, Butylene Glycol, Caprylyl Glycol, Barium Sulfate, Angelica Polymorpha Sinensis Root Extract, HDI/Trimethylol Hexyllactone Crosspolymer, Potassium Sorbate, Hexylene Glycol, Dimethylacrlamide/Acrylic Acid/Polystyrene Ethyl Methacrylate Copolymer, Tranexamic Acid, Triethoxycaprylylsilane, Peat Extract, Trimyristin, Hydrogenated Lecithin, Oligopeptide-10, Tetrapeptide-14, Honey Extrac, Boswellia Serrata Extract, Resveratrol Lecithin, Silver. May contain: Iron Oxides, Titanium Dioxide.

Other information

Protect this product from excessive heat and direct sun.

Rodan + Fields ENHANCEMENTS - Light, Medium, Bronze Product Labels

Prescription for Change™

RODAN+FIELDS®
ENHANCEMENTS

Mineral Peptides

BROAD SPECTRUM SPF 20

RODAN+FIELDS®
DERMATOLOGISTS

4g/0.14 Oz.

Manufactured for Rodan and Fields, LLC 111 Maiden Lane, Suite 400 San Francisco CA 94108 Made in the USA Please Recycle

visit rodanand fields.com  QUESTIONS OR COMMENTS 1-888-995-5656

Light
ENPL004
08-03-0023

Medium
ENPM004
80-03-0024

Bronze
ENPB004
80-03-0025

INGREDIENTS AND APPEARANCE

RODAN AND FIELDS ENHANCEMENTS  LIGHT
titanium dioxide, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54111-119
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.38400 g  in 4 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.19600 g  in 4 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
SQUALANE (UNII: GW89575KF9)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CERAMIDE 3 (UNII: 4370DF050B)
CHOLESTEROL (UNII: 97C5T2UQ7J)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
BARIUM SULFATE (UNII: 25BB7EKE2E)
ANGELICA SINENSIS ROOT (UNII: B66F4574UG)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
TRANEXAMIC ACID (UNII: 6T84R30KC1)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TRIMYRISTIN (UNII: 18L31PSR28)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
HONEY (UNII: Y9H1V576FH)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
RESVERATROL (UNII: Q369O8926L)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SILVER (UNII: 3M4G523W1G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54111-119-50	4 g in 1 JAR; Type 0: Not a Combination Product	08/15/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/15/2012

RODAN AND FIELDS ENHANCEMENTS  MEDIUM
titanium dioxide, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54111-120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.38400 g  in 4 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.19600 g  in 4 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
SQUALANE (UNII: GW89575KF9)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CERAMIDE 3 (UNII: 4370DF050B)
CHOLESTEROL (UNII: 97C5T2UQ7J)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
BARIUM SULFATE (UNII: 25BB7EKE2E)
ANGELICA SINENSIS ROOT (UNII: B66F4574UG)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
TRANEXAMIC ACID (UNII: 6T84R30KC1)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TRIMYRISTIN (UNII: 18L31PSR28)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
HONEY (UNII: Y9H1V576FH)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
RESVERATROL (UNII: Q369O8926L)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SILVER (UNII: 3M4G523W1G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54111-120-50	4 g in 1 JAR; Type 0: Not a Combination Product	09/05/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/05/2012

RODAN AND FIELDS ENHANCEMENTS  BRONZE
titanium dioxide, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54111-121
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.38400 g  in 4 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.19600 g  in 4 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
SQUALANE (UNII: GW89575KF9)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CERAMIDE 3 (UNII: 4370DF050B)
CHOLESTEROL (UNII: 97C5T2UQ7J)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
BARIUM SULFATE (UNII: 25BB7EKE2E)
ANGELICA SINENSIS ROOT (UNII: B66F4574UG)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
TRANEXAMIC ACID (UNII: 6T84R30KC1)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TRIMYRISTIN (UNII: 18L31PSR28)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
HONEY (UNII: Y9H1V576FH)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
RESVERATROL (UNII: Q369O8926L)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SILVER (UNII: 3M4G523W1G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54111-121-50	4 g in 1 JAR; Type 0: Not a Combination Product	04/19/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/19/2013

Labeler - Bentley Laboratories, LLC (068351753)

Registrant - Bentley Laboratories, LLC (068351753)

Establishment
Name	Address	ID/FEI	Business Operations
Bentley Laboratories, LLC		068351753	manufacture(54111-119, 54111-120, 54111-121)