SKINCEUTICALS PHYSICAL EYE UV DEFENSE SUNSCREEN- titanium dioxide and zinc oxide lotion 
L'Oreal USA Products Inc

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Drug Facts

Active ingredients

Titanium dioxide 9%

Zinc oxide 4%

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 at least every 2 hours

● use a water resistant sunscreen if swimming or sweating

● 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

dimethicone, C12-15 alkyl benzoate, triethylhexanoin, isohexadecane, talc, hydrogentated jojoba oil, dimethicone crosspolymer, styrene/acrylates copolymer, C30-45 alkyldimethylsilyl polypropylsilsesquioxane, dimethicone/vinyl dimethicone crosspolymer aluminum stearate, alumina, polyhydroxystearic acid, iron oxides, phenoxyethanol, silica silylate, PEG-8 laurate, triethoxycaprylylsilane, 2-oleamido-1,3-octadecanediol, disodium stearoyl glutamate, paraffin, aluminum hydroxide

Questions or comments?

Call 1-800-811-1660

Monday - Friday

(9 a.m. - 5 p.m. CST)

image of a carton

image of a carton
SKINCEUTICALS PHYSICAL EYE UV DEFENSE SUNSCREEN 
titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE90 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
TALC (UNII: 7SEV7J4R1U)  
HYDROGENATED JOJOBA OIL (UNII: 7F674YQ5SO)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PEG-8 LAURATE (UNII: 762O8IWA10)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
9-OCTADECENAMIDE, N-(2-HYDROXY-1-(HYDROXYMETHYL)HEPTADECYL)-, (9Z)- (UNII: 30D478BUNR)  
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
PARAFFIN (UNII: I9O0E3H2ZE)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-050-011 in 1 CARTON04/18/201407/27/2026
110 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:49967-050-020.15 mL in 1 PACKET; Type 0: Not a Combination Product04/18/201407/27/2026
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/18/201407/27/2026
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
Goodier Cosmetics LP007317209manufacture(49967-050)
Establishment
NameAddressID/FEIBusiness Operations
Beauty Manufacturing Solutions Corp.783200723manufacture(49967-050)

Revised: 12/2023
Document Id: ee667814-d4d3-4886-a7a7-bfaf6c03df0a
Set id: 5fb2ec75-6d79-4b06-839c-2e0976309942
Version: 8
Effective Time: 20231228
 
L'Oreal USA Products Inc