Drug Facts

Manufacturer
L'Oreal USA Products Inc | SICOS ET CIE | BPS60
Effective date
2022-01-04
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 22:19:11

Label at a glance#

ProductLancome Paris Teint Miracle Lit From Within Makeup Broad Spectrum SPF 15 Sunscreen
Active ingredientOCTINOXATE
Label structure14 sections

Indications and 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

Dosage and administration

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 inclu...

Storage and handling

protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 3%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

Flammable until dry.

SAFE HANDLING WARNING SECTION

Do not use near fire, flame or heat

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-800-LANCOME

(1-800-526-2663)

Monday - Friday

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of a labelimage of a label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD513
OCTINOXATEACTIVE MOIETY4Y5P7MUD513

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-50649967-506-01, 49967-506-02, 49967-506-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c32def00-f97c-494c-a3a1-5df83c67b7f431c08353-415f-455c-b62a-abac7703bc612023-01-24WarningsExact identifier
spl set id: 31c08353-415f-455c-b62a-abac7703bc61

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.