KIEHLS SINCE 1851 ACTIVATED SUN PROTECTOR FOR BODY BROAD SPECTRUM SPF 50 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion

Kiehls Since 1851 Activated Sun Protector For Body Broad Spectrum SPF 50 Sunscreen by

Drug Labeling and Warnings

Kiehls Since 1851 Activated Sun Protector For Body Broad Spectrum SPF 50 Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Dimensional Merchandising Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 5%

Oxybenzone 6%

Purpose

Sunscreen

Uses

- helps prevent sunburn

- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

rash occurs

Keep out of reach of children.

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

Directions

For sunscreen use:

● apply liberally 15 minutes before sun exposure

● reapply:

● after 80 minutes of swimming or sweating

● immediately after towel drying

● at least every 2 hours

● Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

● limit time in the sun, especially from 10 a.m. – 2 p.m.

● wear long-sleeved shirts, pants, hats, and sunglasses

● children under 6 months of age: Ask a doctor

Other information

protect the product in this container from excessive heat and direct sun

Inactive ingredients

water, dimethicone, isododecane, styrene/acrylates copolymer, propanediol, silica, isononyl isononanoate, inulin lauryl carbamate, nylon-12, caprylyl methicone, synthetic wax, poly C10-30 alkyl acrylate, p-anisic acid, sucrose tristearate, lycium barbarum fruit extract, tocopherol, hydrolyzed triticum monococcum seed extract, phenoxyethanol, stearyl alcohol, PEG-8 laurate, triethanolamine, polymethyl methacrylate, ammonium acryloyldimethyltaurate/steareth-25 methacrylate crosspolymer, dimethiconol, xanthan gum, disodium EDTA, glycerin

Questions or comments?

Call toll free 1-800-946-4453

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KIEHLS SINCE 1851 ACTIVATED SUN PROTECTOR FOR BODY BROAD SPECTRUM SPF 50 SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-078
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISODODECANE (UNII: A8289P68Y2)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
PROPANEDIOL (UNII: 5965N8W85T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
NYLON-12 (UNII: 446U8J075B)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
SYNTHETIC WAX (2900 MW) (UNII: U5UP035C8A)
P-ANISIC ACID (UNII: 4SB6Y7DMM3)
SUCROSE TRISTEARATE (UNII: 71I93STU5M)
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)
TOCOPHEROL (UNII: R0ZB2556P8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PEG-8 LAURATE (UNII: 762O8IWA10)
TROLAMINE (UNII: 9O3K93S3TK)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
DIMETHICONOL (70 CST) (UNII: MOT8IL21AR)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-078-01	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/01/2012

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Dimensional Merchandising Inc.		076693183	manufacture(49967-078)