TEINT MIRACLE OCTINOXATE SUNSCREEN BROAD SPECTRUM SPF 15- octinoxate cream

Teint Miracle Octinoxate Sunscreen Broad Spectrum SPF 15 by

Drug Labeling and Warnings

Teint Miracle Octinoxate Sunscreen Broad Spectrum SPF 15 by is a Otc medication manufactured, distributed, or labeled by BPS 60, SICOS ET CIE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 untill 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 reaply 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, 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:

INGREDIENTS AND APPEARANCE

TEINT MIRACLE OCTINOXATE SUNSCREEN BROAD SPECTRUM SPF 15 
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70581-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70581-004-01	1 in 1 BOX	04/06/2016
1		110 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/06/2016

Labeler - BPS 60 (272259304)

Establishment
Name	Address	ID/FEI	Business Operations
BPS 60		272259304	pack(70581-004)

Establishment
Name	Address	ID/FEI	Business Operations
SICOS ET CIE		276993581	manufacture(70581-004)