RODAN AND FIELDS UNBLEMISH- titanium dioxide, zinc oxide lotion

RODAN and FIELDS UNBLEMISH by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENTS:

Titanium Dioxide 0.7%
Zinc Oxide 4.75%

PURPOSE:

Sunscreens

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. If 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. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with warm water to remove.

DIRECTIONS:

Apply a generous dime-sized amount evenly over the entire face every morning, 15 minutes before sun exposure, as the final step in the Regimen. Reapply every 2 hours when exposed to the sun. Avoid the eye area.

INACTIVE INGREDIENTS:

Water, Cyclopentasiloxane, Isododecane, Pentylene Glycol, Cetearyl Alcohol, Polysilicone-11, PEG-10 Dimethicone, Butylene Glycol, Polysorbate 60, Dimethicone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, PEG-100 Stearate, Glyceryl Stearate, Caprylyl Glycol, Squalane, Citric Acid, Xanthan Gum, 1,2-Hexanediol, PEG-60 Almond Glycerides, Ceteth-10 Phosphate, Oleanolic Acid, Nordihydroguaiaretic Acid, Glycerin, Carbomer, Chlorphenesin, Dimethiconol, Dicetyl Phosphate, Cholesterol, Hexyl Laurate, Fragrance, Polyglyceryl-4 Isostearate, Potassium Sorbate, Sodium Benzoate, Tocopherol, Disodium EDTA, Tetrahexyldecyl Ascorbate, Azelaic Acid, Stearic Acid, Lecithin, Alumina, Sodium Chondroitin Sulfate, Atelocollagen, Boerhavia Diffusa Root Extract, Methylisothiazolinone, Tropolone

RODAN and FIELDS UNBLEMISHED Label

RODAN and FIELDS UNBLEMISHED

4 Oil Control Lotion

BROAD SPECTRUM SPF 20 SUNSCREEN

Manufactured for Rodan and Fields, LLC
San Francisco, CA 94105
Made in USA  UNSS030  85-07-0015
Please recycle
visit rodanandfields.com

QUESTIONS OR COMMENTS
1-888-995-5656

30mL/1 Fl. Oz.

INGREDIENTS AND APPEARANCE

RODAN AND FIELDS UNBLEMISH 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54111-122
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.21000 g  in 30 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.42500 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISODODECANE (UNII: A8289P68Y2)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYSORBATE 60 (UNII: CAL22UVI4M)
DIMETHICONE (UNII: 92RU3N3Y1O)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SQUALANE (UNII: GW89575KF9)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
XANTHAN GUM (UNII: TTV12P4NEE)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
MASOPROCOL (UNII: 7BO8G1BYQU)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
CHOLESTEROL (UNII: 97C5T2UQ7J)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TOCOPHEROL (UNII: R0ZB2556P8)
EDETATE SODIUM (UNII: MP1J8420LU)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
AZELAIC ACID (UNII: F2VW3D43YT)
STEARIC ACID (UNII: 4ELV7Z65AP)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)
BOERHAVIA DIFFUSA ROOT (UNII: KR0SR09KYL)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
TROPOLONE (UNII: 7L6DL16P1T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54111-122-50	30 mL in 1 TUBE; Type 0: Not a Combination Product	03/05/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/05/2010

Labeler - Bentley Laboratories, LLC (068351753)

Registrant - Bentley Laboratories, LLC (068351753)

Establishment
Name	Address	ID/FEI	Business Operations
Bentley Laboratories, LLC		068351753	manufacture(54111-122)