RODAN FIELDS SOOTHE 4 MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- titanium dioxide cream

RODAN FIELDS SOOTHE 4 Mineral Sunscreen BROAD SPECTRUM SPF 30 by

Drug Labeling and Warnings

RODAN FIELDS SOOTHE 4 Mineral Sunscreen BROAD SPECTRUM SPF 30 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 + FIELDS SOOTHE 4 Mineral Sunscreen BROAD SPECTRUM SPF 30

ACTIVE INGREDIENTS:

Titanium Dioxide 2%
Zinc Oxide 12%

PURPOSE

Sunscreens

USES:

To protect from sunburn and sun-induced skin irritations.

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 water to remove.

Keep out of reach of children.

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

DIRECTIONS:

Shake well before use. Apply a generous dime-sized amount evenly over the entire face every morning as the final step in the Regimen. Reapply every 2 - 3 hours as needed. Avoid the eye area. Children under 6 months of age: ask a doctor.

INACTIVE INGREDIENTS:

Alumina, Aluminum Starch Octenylsuccinate, Butylene Glycol, Camellia Sinesis Extract, Caprylyl Glycol, Caprylyl Methicone, Cyclopentasiloxane, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Dipotassium
Glycyrrhizate, Disodium EDTA, Disteardimonium Hectorite, Ethylhexylglycerin, Glycerin, Glycyrrhiza Glabra (Licorice) Root Extract, Hydrolyzed Wheat Protein/PVP Crosspolymer, Methicone, Panthenol, PEG-10 Dimethicone, Phenoxyethanol, Silica, Sodium Chloride, Sodium Hyaluronate, Sodium PCA, Tocopheryl Acetate, Water

OTHER INFORMATION

Protect this product from excessive heat and direct sun.

RODAN + FIELDS SOOTHE 4 Mineral Sunscreen BROAD SPECTRUM SPF 30 50ml (

14222-0000-1)

INGREDIENTS AND APPEARANCE

RODAN FIELDS SOOTHE 4 MINERAL SUNSCREEN BROAD SPECTRUM SPF 30  
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14222-0000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	20 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	120 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM OXIDE (UNII: LMI26O6933)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
LICORICE (UNII: 61ZBX54883)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)
PANTHENOL (UNII: WV9CM0O67Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14222-0000-1	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	06/03/2013

Labeler - Rodan & Fields (051659584)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab, Inc.		080366903	manufacture(14222-0000)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab Korea Co., Ltd.		690104005	manufacture(14222-0000)