SKINCEUTICALS PHYSICAL UV DEFENSE BROAD SPECTRUM SPF 30 SUNSCREEN- titanium dioxide and zinc oxide cream 
L'Oreal USA Products Inc

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Drug Facts

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)

image of a carton

SKINCEUTICALS PHYSICAL UV DEFENSE BROAD SPECTRUM SPF 30 SUNSCREEN 
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-472
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE50 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-472-011 in 1 CARTON01/01/2012
150 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:49967-472-024 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/01/2012
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Essence, LLC032565959manufacture(49967-472)
Establishment
NameAddressID/FEIBusiness Operations
Goodier Cosmetics LP007317209manufacture(49967-472)

Revised: 12/2023
Document Id: f7d15171-ddc7-47a2-a743-afa219aa8142
Set id: 3a6db7d3-6c59-4633-a97e-1c03127246d3
Version: 7
Effective Time: 20231228
 
L'Oreal USA Products Inc