KIEHLS SINCE 1851 CROSSTERRAIN UV SKIN PROTECTOR BROAD SPECTRUM SPF 50 SUNSCREEN WATER RESISTANT 80 MINUTES- avobenzone, homosalate, octisalate, octocrylene and oxybenzone ointment

Kiehls Since 1851 CrossTerrain UV Skin Protector Broad Spectrum SPF 50 Sunscreen Water Resistant 80 Minutes by

Drug Labeling and Warnings

Kiehls Since 1851 CrossTerrain UV Skin Protector Broad Spectrum SPF 50 Sunscreen Water Resistant 80 Minutes by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 7.5%

Oxybenzone 5%

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

synthetic beeswax, isodecyl neopentanoate, C10-18 triglycerides, hydrogenated castor oil, euphorbia cerifera (candelilla) wax, isopropyl palmitate, caprylic/capric triglyceride, squalane, isopropyl myristate, isodecyl salicylate, ozokerite, sorbitan isostearate, stearalkonium hectorite, PEG-5, pentaerythrityl ether, PPG-5 pentaerythrityl ether, polyisobutene, propylene carbonate, glycine soja (soybean) sterols, tocopheryl acetate

Questions or comments?

Call toll free 1-800-946-4453

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KIEHLS SINCE 1851 CROSSTERRAIN UV SKIN PROTECTOR BROAD SPECTRUM SPF 50 SUNSCREEN WATER RESISTANT 80 MINUTES 
avobenzone, homosalate, octisalate, octocrylene and oxybenzone ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-821
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	100 min  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	75 mg  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SYNTHETIC WAX (2900 MW) (UNII: U5UP035C8A)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
SQUALANE (UNII: GW89575KF9)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ISODECYL SALICYLATE (UNII: S7097PFP4C)
CERESIN (UNII: Q1LS2UJO3A)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
POLYETHYLENE GLYCOL 250 (UNII: 5246R0812J)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SOY STEROL (UNII: PL360EPO9J)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-821-01	40 g in 1 JAR; Type 0: Not a Combination Product	06/01/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2010

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA Products Inc		185931458	manufacture(49967-821)