SKINCEUTICALS PHYSICAL UV DEFENSE BROAD SPECTRUM SPF 30 SUNSCREEN- titanium dioxide and zinc oxide cream

SkinCeuticals Physical UV Defense Broad Spectrum SPF 30 Sunscreen by

Drug Labeling and Warnings

SkinCeuticals Physical UV Defense Broad Spectrum SPF 30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Cosmetic Essence, LLC, Goodier Cosmetics LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Titanium dioxide 5%

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

● shake well before 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

water, glycerin, c12-15 alkyl benzoate, dimethicone, butyloctyl salicylate, phenethyl benzoate, triethylhexanoin, isohexadecane, styrene/acrylates copolymer, stearyl dimethicone, butyrospermum parkii (shea) butter, isododecane, polyglyceryl-4 isostearate, talc, dimethicone/polyglycerin-3 crosspolymer, nylon-12, pentylene glycol, lauryl PEG-9 polydimethylsiloxyethyl dimethicone, aluminum stearate, phenoxyethanol, alumina, polyhydroxystearic acid, magnesium sulfate, caprylyl glycol, PEG-8 laurate, disteardimonium hectorite, triethoxycaprylylsilane, tocopherol, propylene carbonate, artemia extract, benzoic acid, dipropylene glycol, sodium hyaluronate

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 UV DEFENSE BROAD SPECTRUM SPF 30 SUNSCREEN 
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-472
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	50 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PHENETHYL BENZOATE (UNII: 0C143929GK)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
ISOHEXADECANE (UNII: 918X1OUF1E)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
STEARYL TRISILOXANE (UNII: 796MG354ZZ)
SHEA BUTTER (UNII: K49155WL9Y)
ISODODECANE (UNII: A8289P68Y2)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
TALC (UNII: 7SEV7J4R1U)
NYLON-12 (UNII: 446U8J075B)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PEG-8 LAURATE (UNII: 762O8IWA10)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TOCOPHEROL (UNII: R0ZB2556P8)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
ARNICA MONTANA (UNII: O80TY208ZW)
BENZOIC ACID (UNII: 8SKN0B0MIM)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-472-01	1 in 1 CARTON	01/01/2012
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2012

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
GOODIER COSMETICS LP		007317209	manufacture(49967-472)