SKINCEUTICALS PHYSICAL FUSION UV DEFENSE BROAD SPECTRUM SPF 50 SUNSCREEN- titanium dioxide and zinc oxide lotion 
L'Oreal USA Products Inc

----------

Drug Facts

Active ingredients

Titanium dioxide 6%

Zinc oxide 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

● apply liberally 15 minutes before sun exposure

● reapply:

    ● after 40 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

water, dimethicone, isododecane, c12-15 alkyl benzoate, undecane, triethylhexanoin, isohexadecane, nylon-12, caprylyl methicone, butyloctyl salicylate, phenethyl benzoate, styrene/acrylates copolymer, silica, tridecane, dicaprylyl carbonate, dicaprylyl ether, talc, dimethicone/PEG-10/15 crosspolymer, aluminum stearate, pentylene glycol, PEG-9 polydimethylsiloxyethyl dimethicone, alumina, polyhydroxystearic acid, phenoxyethanol, magnesium sulfate, caprylyl glycol, iron oxides, PEG-8 laurate, disteardimonium hectorite, triethoxycaprylylsilane, tocopherol, propylene carbonate, artemia extract, benzoic acid, PEG-9, disodium stearoyl glutamate, 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 FUSION UV DEFENSE BROAD SPECTRUM SPF 50 SUNSCREEN 
titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-077
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE60 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISODODECANE (UNII: A8289P68Y2)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
UNDECANE (UNII: JV0QT00NUE)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
NYLON-12 (UNII: 446U8J075B)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
PHENETHYL BENZOATE (UNII: 0C143929GK)  
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TRIDECANE (UNII: A3LZF0L939)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
TALC (UNII: 7SEV7J4R1U)  
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
PEG-8 LAURATE (UNII: 762O8IWA10)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
TOCOPHEROL (UNII: R0ZB2556P8)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
POLYETHYLENE GLYCOL 450 (UNII: 5IRA46LB71)  
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-077-011 in 1 CARTON01/01/2011
150 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:49967-077-024 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2011
3NDC:49967-077-03125 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2011
4NDC:49967-077-04250 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/01/2011
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
Goodier Cosmetics LP007317209manufacture(49967-077)

Revised: 12/2023
Document Id: 8aa3392a-bb65-475b-8bca-4da38eacd4e5
Set id: 8df98d97-a5d2-4d52-8bd2-130a13501d60
Version: 9
Effective Time: 20231228
 
L'Oreal USA Products Inc