KIEHLS ACTIVATED SUN PROTECTOR SUNSCREEN SPF 50 FOR FACE AND BODY FOR ALL SKIN TYPES- ethylhexyl triazone, drometrizole trisiloxane, homosalate, terephthalylidene dicamphor sulfonic acid, ethylhexyl salicylate, bis-ethylhexyloxyphenol methoxyphenyl triazine and diethylamino hydroxybenzoyl hexyl benzoate lotion

Kiehls Activated Sun Protector Sunscreen SPF 50 For Face and Body For All Skin Types by

Drug Labeling and Warnings

Kiehls Activated Sun Protector Sunscreen SPF 50 For Face and Body For All Skin Types by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Cosmetic Essence, LLC, Universal Packaging Systems, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Directions

Apply liberally and evenly onto face and/or body prior to sun exposure and massage into skin for complete coverage. Avoid the eye area. Leave ot dry and apply a second time to ensure a generous application. An insufficient amount of product reduces the level of protection. Re-apply frequently to maintain protection, especially after swimming, perspiring, or using a towel. Over-exposure to tht sun is dangerous. Keep babies and young children out of direct sunlight, and well covered. Do not stay too long in the sun, even while using a sunscreen product, because it does not provide you 100% protection. In case of contact with eyes, rinse them immediately and thoroughly.

Ingredients

Ethylhexyl Triazone, Drometrizole Trisiloxane, Homosalate, Terephthalylidene Dicamphor Sulfonic Acid, Ethyhexyl Salicylate, Bis-Ethylhexyloxyphenol methoxyphenyl triazine, Diethylamino hydroxybenzoyl hexyl benzoate

Ingredients

Aqua/Water, Glycerin, C12-15 Alkyl Benzoate, Alcohol Denat., Zea Mays Starch/Corn Starch, Propylene Glycol, Synthetic Wax, Sulfonic Acid, Stearic Acid, Palmitic Acid, PEG-100 Stearate, Glyceryl Stearate, Parfum/Fragrance, Caprylyl Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Stearoyl Glutamate, Glycine Soja Oil/Soybean Oil, Tocopherol, Xanthan Gum, Benzyl Salicylate, Benzyl Alcohol, Myristic Acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KIEHLS ACTIVATED SUN PROTECTOR SUNSCREEN SPF 50 FOR FACE AND BODY FOR ALL SKIN TYPES 
ethylhexyl triazone, drometrizole trisiloxane, homosalate, terephthalylidene dicamphor sulfonic acid, ethylhexyl salicylate, bis-ethylhexyloxyphenol methoxyphenyl triazine and diethylamino hydroxybenzoyl hexyl benzoate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4) (ETHYLHEXYL TRIAZONE - UNII:XQN8R9SAK4)	ETHYLHEXYL TRIAZONE	30 mg  in 1 mL
DROMETRIZOLE TRISILOXANE (UNII: HC22845I1X) (DROMETRIZOLE TRISILOXANE - UNII:HC22845I1X)	DROMETRIZOLE TRISILOXANE	50 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
ECAMSULE (UNII: M94R1PM439) (ECAMSULE - UNII:M94R1PM439)	ECAMSULE	30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH)	BEMOTRIZINOL	40 mg  in 1 mL
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20) (DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE - UNII:ANQ870JD20)	DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ALCOHOL (UNII: 3K9958V90M)
STARCH, CORN (UNII: O8232NY3SJ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
SULFURIC ACID (UNII: O40UQP6WCF)
STEARIC ACID (UNII: 4ELV7Z65AP)
PEG-100 STEARATE (UNII: YD01N1999R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
XANTHAN GUM (UNII: TTV12P4NEE)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
BENZYL ALCOHOL (UNII: LKG8494WBH)
MYRISTIC ACID (UNII: 0I3V7S25AW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-123-01	150 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2014
2	NDC: 49967-123-02	5 mL in 1 PACKET; Type 0: Not a Combination Product	01/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
export only		01/01/2014

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA, INC.		185931458	manufacture(49967-123)