KIEHLS ULTRA LIGHT DAILY UV DEFENSE SUNSCREEN- drometrizole trisiloxane, octinoxate and ecamsule lotion

Kiehls Ultra Light Daily UV Defense Sunscreen by

Drug Labeling and Warnings

Kiehls Ultra Light Daily UV Defense Sunscreen 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]

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. 

Over-exposure to the sun in dangerous. Keep babies and young children out of direct sunlight. Do not stay too long in the sun, even while using a sunscreen product because it does not provide you 100% protection. Apply the sunscreen product just before sun exposure. Re-apply frequently and generously to maintain protection, especially after swimming, perspiring or toweling.

Inactive ingredients

water, dimethicone, glycerin, propylene glycol, titanium dioxide, alcohol denat., triethanolamine, stearic acid, potassium cetyl phosphate, nylon-12, palmitic acid, PEG-100 stearate, glyceryl stearate, cetyl alcohol, bis-ethylhexyloxyphenol methoxyphenyl triazine, phenoxyethanol, diethylamino hydroxybenzoyl hexyl benzoate, aluminum hydroxide, methylparaben, sodium cocoyl sarcosinate, caprylyl glycol, carbomer, tocopherol, tromethamine, ethylparaben, acrylamide/sodium acryloyldimethyltaurate copolymer, isohexadecane, xanthan gum, disodium EDTA, adenosine, arginine, polysorbate 80, mannitol, RNA, pyridoxine HCL, disodium adenosine triphosphate, histidine HCL, zea mays extract/corn kernel extract, phenylalanine, faex extract/yeast extract, tyrosine, mentha piperita extract/peppermint leaf extract, rosa gallica extract/rosa gallica flower extract

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KIEHLS ULTRA LIGHT DAILY UV DEFENSE SUNSCREEN 
drometrizole trisiloxane, octinoxate and ecamsule lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-258
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
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	67.5 mg  in 1 mL
ECAMSULE (UNII: M94R1PM439) (ECAMSULE - UNII:M94R1PM439)	ECAMSULE	120 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
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)
CETYL ALCOHOL (UNII: 936JST6JCN)
BEMOTRIZINOL (UNII: PWZ1720CBH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM COCOYL SARCOSINATE (UNII: 1R9DUY89CZ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TOCOPHEROL (UNII: R0ZB2556P8)
TROMETHAMINE (UNII: 023C2WHX2V)
ETHYLPARABEN (UNII: 14255EXE39)
ISOHEXADECANE (UNII: 918X1OUF1E)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ADENOSINE (UNII: K72T3FS567)
ARGININE (UNII: 94ZLA3W45F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
MANNITOL (UNII: 3OWL53L36A)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
ADENOSINE TRIPHOSPHATE DISODIUM (UNII: 5L51B4DR1G)
HISTIDINE MONOHYDROCHLORIDE (UNII: 1D5Q932XM6)
PHENYLALANINE (UNII: 47E5O17Y3R)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
TYROSINE (UNII: 42HK56048U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-258-01	1 in 1 CARTON	01/01/2022
1		60 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49967-258-02	1 in 1 CARTON	01/01/2022
2		30 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 49967-258-03	1 in 1 CARTON	01/01/2022
3		5 mL in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 49967-258-04	1 in 1 CARTON	01/01/2022
4		3 mL in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 49967-258-05	1.5 mL in 1 PACKET; Type 0: Not a Combination Product	01/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
export only		01/01/2022

Labeler - L'Oreal USA Products Inc. (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA, INC.		185931458	manufacture(49967-258) , pack(49967-258)