LANCOME PARIS PHOTOGENIC LUMESSENCE LIGHT MASTERING AND LINE SMOOTHING MAKEUP NORMAL TO DRY SKIN BROAD SPECTRUM SPF 15 SUNSCREEN- octinoxate lotion 
L’Oreal USA Products Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

Octinoxate 5%

Purpose

Sunscreen

Use

  • 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:
● shake well

● 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, cyclopentasiloxane, dimethicone, glycerin, HDI/trimethylol hexyllactone crosspolymer, PEG-10 dimethicone, dimethicone/PEG-10/15 crosspolymer, dimethicone/polyglycerin-3 crosspolymer, bis-diglyceryl polyacyladipate-2, sodium hyaluronate, aluminum hydroxide, magnesium sulfate, disodium stearoyl glutamate, propylene glycol, citronellol, pentylene glycol, butylphenyl methylpropional, fragrance, hydroxyisohexyl 3-cyclohexene carboxaldehyde, hexyl cinnamal, methylparaben, phenoxyethanol, butylparaben, diazolidinyl urea; may contain: mica, titanium dioxide, iron oxides

Questions or comments?

1-800-LANCOME

(1-800-526-2663)

Monday - Friday

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

image of a carton

LANCOME PARIS PHOTOGENIC LUMESSENCE LIGHT MASTERING AND LINE SMOOTHING MAKEUP NORMAL TO DRY SKIN BROAD SPECTRUM SPF 15 SUNSCREEN 
octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-867
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-867-011 in 1 CARTON12/23/201009/02/2020
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/23/201009/02/2020
Labeler - L’Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L’Oreal USA, Inc.185931458analysis(49967-867)
Establishment
NameAddressID/FEIBusiness Operations
Value Added Services LLC036822144manufacture(49967-867) , pack(49967-867)

Revised: 9/2020
 
L’Oreal USA Products Inc