KIEHLS DERMATOLOGIST SOLUTIONS ULTRA LIGHT DAILY UV DEFENSE SUNSCREEN SPF 50 HIGH PROTECTION ANTI-POLLUTION LIGHTWEIGHT FORMULA FOR ALL SKIN TYPES- drometrizole trisiloxane, titanium dioxide, ecamsule, bemotrizinol, diethylamino hydroxybenzoyl hexyl benzoate and octinoxate lotion

KIEHLS DERMATOLOGIST SOLUTIONS ULTRA LIGHT DAILY UV DEFENSE SUNSCREEN SPF 50 HIGH PROTECTION ANTI-POLLUTION LIGHTWEIGHT FORMULA FOR ALL SKIN TYPES by

Drug Labeling and Warnings

KIEHLS DERMATOLOGIST SOLUTIONS ULTRA LIGHT DAILY UV DEFENSE SUNSCREEN SPF 50 HIGH PROTECTION ANTI-POLLUTION LIGHTWEIGHT FORMULA FOR ALL SKIN TYPES by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products, Inc., L'OREAL USA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Ingredients

Drometrizole Trisiloxane

Titanium Dioxide

Terephthalylidene Dicamphor Sulfonic Acid

Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine

Diethylamino Hydroxybenzoyl Hexyl Benzoate

Ethylhexyl Methoxycinnamate

Ingredients

Aqua/Water, Glycerin, Propylene Glycol, Alcohol Denat., Triethanolamine, Stearic Acid, Potassium Cetyl Phosphate, Nylon-12, Palmitic Acid, PEG-100 Stearate, Glyceryl Stearate, Phenoxyethanol, Cetyl Alcohol, Cellulose, Citric Acid, Aluminum Hydroxide, Caprylyl Glycol, Sodium Cocoyl Sarcosinate, Carbomer, Tocopherol, Tromethanime, Scutellaria Baicalensis Extract/Scutellaria Baicalensis Root Extract, Acrylamide/Sodium Acryloyldimethyltaurate Copolymer, Isohexadecane, Xanthan Gum, Myristic Acid, Disodium EDTA, Adenosine, Polysorbate 80, Arginine, Mannitol, Disodium Adenosine Triphosphate, RNA, Pyridoxane HCL, Sorbitan Oleate, Sorbitol, Pentylene Glycol, BHT, Histidine HCL, Zea Mays Kernel Extract/Corn Kernel Extract, Sodium Chloride, Faex Extract/Yeast Extract, Phenylalanine, Mentha Piperita Extract/Perppermint Extract, Rosa Gallica Flower Extract, Tyrosine, Sorbic Acid

Directions

Apply in the morning at the end of your daily skincare routine. Avoid eye area. In case of contact with eyes, rinse immediately and thoroughly.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KIEHLS DERMATOLOGIST SOLUTIONS ULTRA LIGHT DAILY UV DEFENSE SUNSCREEN SPF 50 HIGH PROTECTION ANTI-POLLUTION LIGHTWEIGHT FORMULA FOR ALL SKIN TYPES 
drometrizole trisiloxane, titanium dioxide, ecamsule, bemotrizinol, diethylamino hydroxybenzoyl hexyl benzoate and octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-449
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DROMETRIZOLE TRISILOXANE (UNII: HC22845I1X) (DROMETRIZOLE TRISILOXANE - UNII:HC22845I1X)	DROMETRIZOLE TRISILOXANE	40 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	40 mg  in 1 mL
ECAMSULE (UNII: M94R1PM439) (ECAMSULE - UNII:M94R1PM439)	ECAMSULE	120 mg  in 1 mL
BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH)	BEMOTRIZINOL	5 mg  in 1 mL
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20) (DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE - UNII:ANQ870JD20)	DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE	5 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	67.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALCOHOL (UNII: 3K9958V90M)
TROLAMINE (UNII: 9O3K93S3TK)
STEARIC ACID (UNII: 4ELV7Z65AP)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
NYLON-12 (UNII: 446U8J075B)
PALMITIC ACID (UNII: 2V16EO95H1)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETYL ALCOHOL (UNII: 936JST6JCN)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM COCOYL SARCOSINATE (UNII: 1R9DUY89CZ)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
TOCOPHEROL (UNII: R0ZB2556P8)
TROMETHAMINE (UNII: 023C2WHX2V)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
ISOHEXADECANE (UNII: 918X1OUF1E)
XANTHAN GUM (UNII: TTV12P4NEE)
MYRISTIC ACID (UNII: 0I3V7S25AW)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ADENOSINE (UNII: K72T3FS567)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ARGININE (UNII: 94ZLA3W45F)
MANNITOL (UNII: 3OWL53L36A)
ADENOSINE TRIPHOSPHATE DISODIUM (UNII: 5L51B4DR1G)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
sorbitol (UNII: 506T60A25R)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HISTIDINE MONOHYDROCHLORIDE (UNII: 1D5Q932XM6)
CORN (UNII: 0N8672707O)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
PHENYLALANINE (UNII: 47E5O17Y3R)
mentha piperita (UNII: 79M2M2UDA9)
ROSA GALLICA FLOWER (UNII: X8W61WUV70)
TYROSINE (UNII: 42HK56048U)
SORBIC ACID (UNII: X045WJ989B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-449-01	1 in 1 CARTON	12/01/2017
1		60 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49967-449-02	1 in 1 CARTON	12/01/2017
2		30 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 49967-449-03	5 mL in 1 TUBE; Type 0: Not a Combination Product	12/01/2017
4	NDC: 49967-449-04	3 mL in 1 PACKET; Type 0: Not a Combination Product	12/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
export only		12/01/2017

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA, INC.		185931458	manufacture(49967-449)