FDA.reportPublic FDA data

Drug Facts

Manufacturer
L'Oreal USA Products Inc | L'Oreal USA, Inc.
Effective date
2023-12-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:06:05

Label at a glance#

ProductKiehls Since 1851 Activated Sun Protector Broad Spectrum SPF 30 Sunscreen Water Resistant 80 MInutes
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Label structure13 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: ●  apply liberally 15 minutes before sun exposure ●  reapply:     ●  after 80 minutes of swimming or sweating     ●  immediately after towel drying     ●  at least every 2 hours ● 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 ...

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

Avobenzone 2.24%

Homosalate 8%

Octisalate 2.4%

Octocrylene 4.48%

Oxybenzone 2.88%

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

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:

●  apply liberally 15 minutes before sun exposure

●  reapply:

    ●  after 80 minutes of swimming or sweating

    ●  immediately after towel drying

    ●  at least every 2 hours

● 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, alcohol denat., dimethicone, cyclopentasiloxane, acrylates/dimethicone copolymer, phenoxyethanol, caprylyl glycol, sodium polyacrylate, silica, acrylates/C10-30 alkyl acrylate crosspolymer, tocopherol, menthyl lactate, disodium EDTA

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-946-4453

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of a labelimage of a label

image of a label
image of a label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-971-01Kiehls Since 1851 Activated Sun Protector Broad Spectrum SPF 30 Sunscreen Water Resistant 80 MInutes150 mL in 1 TUBELOTION1504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-971KIEHLS SINCE 1851 ACTIVATED SUN PROTECTOR BROAD SPECTRUM SPF 30 SUNSCREEN WATER RESISTANT 80 MINUTES (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [L'OREAL USA PRODUCTS INC]4Current NDC, Legacy NDC, 1 package rows20231231_2d2fbd8b-a90f-465a-9bf3-75cd6abdc6d3.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-97149967-971-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
DIMETHICONE92RU3N3Y1OIACT
CYCLOMETHICONE 50THT5PCI0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TOCOPHEROLR0ZB2556P8IACT
MENTHYL LACTATE, (-)-2BF9E65L7IIACT

Source Document#

Source XML

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
Kiehls Since 1851 Activated Sun Protector Broad Spectrum SPF 30 Sunscreen Water Resistant 80 MInutesAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONEL'Oreal USA Products Inc2d2fbd8b-a90f-465a-9bf3-75cd6abdc6d32023-12-30WarningsExact identifier
ndc (package): 49967-971-01
ndc (product): 49967-971
ndc11 (package): 49967097101
spl id: cac3e9bc-baae-4979-b643-23992b3a0748
spl set id: 2d2fbd8b-a90f-465a-9bf3-75cd6abdc6d3

Reported adverse events (FAERS/openFDA)#

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