SKINCEUTICALS PHYSICAL EYE UV DEFENSE SUNSCREEN- titanium dioxide and zinc oxide lotion

SkinCeuticals Physical Eye UV Defense Sunscreen by

Drug Labeling and Warnings

SkinCeuticals Physical Eye UV Defense Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Goodier Cosmetics LP, Beauty Manufacturing Solutions Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SKINCEUTICALS PHYSICAL EYE UV DEFENSE SUNSCREEN 
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	90 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-050-01	1 in 1 CARTON	04/18/2014
1		10 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49967-050-02	0.15 mL in 1 PACKET; Type 0: Not a Combination Product	04/18/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/18/2014

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Goodier Cosmetics LP		007317209	manufacture(49967-050)