TEINT MIRACLE OCTINOXATE SUNSCREEN BROAD SPECTRUM SPF 15- octinoxate cream 
BPS 60

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Teint Miracle Octinoxate Sunscreen Broad Spectrum SPF 15

Drug Facts

Active ingredient

Octinoxate 3%

Purpose

Sunscreen

uses

Warnings

For external use only

Do not use near fire, flame or heat. Flammable untill dry.

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 • reaply at least every 2 hours • use a water resistant sunscreen if swimming or sweating • 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



Sun Protection Measures.

Other information

Inactive ingredients

water, cyclopentasiloxane, alcohol denat., phenyl trimethicone, glycerin, PEG-10 dimethicone, bis-PEG/PPG-14/14 dimethicone, tin oxide, PEG/PPG/polybutylene glycol-8/5/3 glycerin, rosa gallica flower extract, talc, dimethicone, dimethicone/polyglycerin-3 crosspolymer, methicone, silica silylate, alumina, aluminum hydroxide, magnesium silicate, magnesium sulfate, disodium stearoyl glutamate, synthetic fluorphlogopite, ethylhexyl hydroxystearate, tocopheryl acetate, fragrance, linalool, limonene, hydroxyisohexyl 3-cyclohexene carboxaldehyde, butylphenyl methylpropional, hexyl cinnamal; may contain: red28 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)

Package Labeling:

Label2

TEINT MIRACLE OCTINOXATE SUNSCREEN BROAD SPECTRUM SPF 15 
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70581-004
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
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
ETHYLHEXYL HYDROXYSTEARATE (UNII: B7I80BVV5E)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70581-004-011 in 1 BOX04/06/2016
1110 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/06/2016
Labeler - BPS 60 (272259304)
Establishment
NameAddressID/FEIBusiness Operations
BPS 60272259304pack(70581-004)
Establishment
NameAddressID/FEIBusiness Operations
SICOS ET CIE276993581manufacture(70581-004)

Revised: 12/2023
Document Id: 0c105dba-8846-8ec8-e063-6294a90a650a
Set id: 9af44d18-d9b4-48eb-8484-a3b84b7bd115
Version: 8
Effective Time: 20231209
 
BPS 60