KIEHLS SINCE 1851 ACTIVATED SUN PROTECTOR BROAD SPECTRUM SPF 50 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene and oxybenzone aerosol, spray

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

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 7%

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

Contents under pressure.

Do not puncture or incinerate. Do not store at temperatures above 120F.

Do not use

on damaged or broken skin

When using this product

• keep out of eyes. Rinse with water to remove.
• keep away from face to avoid breathing it

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:

● spray liberally and spread evenly by hand 15 minutes before sun exposure

● hold container 4 to 6 inches from the skin to apply

● do not spray directly into face. Spray on hands then apply to face.

● do not apply in windy conditions

● use in a well-ventilated area

● 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

Inactive ingredients

dimethicone, water, isododecane, isononyl isononanoate, PEG-10 dimethicone, styrene/acrylates copolymer, PEG-30 dipolyhydroxystearate, dicaprylyl carbonate, trisiloxane, dimethicone/PEG-10/15 crosspolymer, sodium chloride, phenoxyethanol, PEG-8 laurate, disteardimonium hectorite, p-anisic acid, disodium EDTA, tocopherol, propylene carbonate

Questions or comments?

Call toll free 1-800-946-4453

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KIEHLS SINCE 1851 ACTIVATED SUN PROTECTOR BROAD SPECTRUM SPF 50 SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene and oxybenzone aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-125
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 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
ISODODECANE (UNII: A8289P68Y2)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
TRISILOXANE (UNII: 9G1ZW13R0G)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-8 LAURATE (UNII: 762O8IWA10)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
P-ANISIC ACID (UNII: 4SB6Y7DMM3)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TOCOPHEROL (UNII: R0ZB2556P8)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-125-01	143 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/01/2013

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Accra Pac, Inc.		024213616	manufacture(49967-125)