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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

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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 TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-821
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate100 min  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene75 mg  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-821-0140 g in 1 JAR; Type 0: Not a Combination Product06/01/201010/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/201010/01/2016
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'Oreal USA Products Inc185931458manufacture(49967-821)

Revised: 1/2023
 
L'Oreal USA Products Inc