LANCOME PARIS TEINT MIRACLE LIT FROM WITHIN MAKEUP BROAD SPECTRUM SPF 15 SUNSCREEN- octinoxate liquid 
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 3%

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

Flammable until dry.

Do not use near fire, flame or heat

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, alcohol denat., phenyl trimethicone, glycerin, PEG-10 dimethicone, bis-PEG/PPG-14/14 dimethicone, PEG/PPG/polybutylene glycol-8/5/3 glycerin, rosa gallica flower extract, talc, dimethicone, dimethicone/polyglycerin-3 crosspolymer, methicone, alumina, aluminum hydroxide, magnesium sulfate, disodium stearoyl glutamate, ethylhexyl hydroxystearate, polyethylene glycol, tocopheryl acetate; may contain: red 28 lake, red 7, mica, titanium dioxide, blue 1 lake, bismuth oxychloride, 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 TEINT MIRACLE LIT FROM WITHIN MAKEUP BROAD SPECTRUM SPF 15 SUNSCREEN 
octinoxate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-506
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
ALCOHOL (UNII: 3K9958V90M)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
ROSA GALLICA FLOWER (UNII: X8W61WUV70)  
TALC (UNII: 7SEV7J4R1U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
ETHYLHEXYL HYDROXYSTEARATE (UNII: B7I80BVV5E)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-506-011 in 1 CARTON04/01/201101/08/2020
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:49967-506-021 in 1 CARTON04/01/201101/08/2020
210 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:49967-506-03110 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/201101/08/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/01/201101/08/2020
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
SICOS ET CIE276993581manufacture(49967-506) , pack(49967-506)
Establishment
NameAddressID/FEIBusiness Operations
BPS60272259304pack(49967-506)

Revised: 1/2023
 
L'Oreal USA Products Inc