Drug Facts

Manufacturer
L'Oreal USA Products Inc | L'Oreal USA, Inc.
Effective date
2025-07-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:07:07

Label at a glance#

ProductKiehls Dermatologist Solutions Better Screen UV Serum Broad Spectrum SPF 50 Plus Sunscreen
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
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

shake well before use 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 t...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 7%

Octisalate 5%

Octocrylene 7%

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

Flammble until dry. 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

  • shake well before use
  • 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. - 2p.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, glycerin, c15-19 alkane, propanediol, c12-22 alkyl acrylate/hydroxyethylacrylate copolymer, tocopherol, sodium stearoyl glutamate, butylene glycol, cetearyl alcohol, sclerotium gum, hydroxyacetophenone, caprylyl glycol, sodium starch octenylsuccinate, glyceryl stearate, jojoba esters, helianthus annuus (sunflower) seed wax, hydroxypropyl starch phosphate, trisodium ethylenediamine disuccinate, carbomer, sodium lactate, sodium hydroxide, polysorbate 20, polyglycerin-3, palmitoyl tripeptide-1, palmitoyl tetrapeptide-7

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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image of a carton
image of a carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of 100 ml bottle primaryimage of 100 ml bottle primaryimage of 100 ml bottle primaryimage of 100 ml bottle primary

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of 100 mL secondaryimage of 100 mL secondaryimage of 100 mL secondaryimage of 100 mL secondary

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-053-01Kiehls Dermatologist Solutions Better Screen UV Serum Broad Spectrum SPF 50 Plus Sunscreen50 mL in 1 BOTTLELOTION503
49967-053-01Kiehls Dermatologist Solutions Better Screen UV Serum Broad Spectrum SPF 50 Plus Sunscreen1 in 1 CARTONLOTION13
49967-053-02Kiehls Dermatologist Solutions Better Screen UV Serum Broad Spectrum SPF 50 Plus Sunscreen15 mL in 1 TUBELOTION153
49967-053-02Kiehls Dermatologist Solutions Better Screen UV Serum Broad Spectrum SPF 50 Plus Sunscreen1 in 1 CARTONLOTION13
49967-053-03Kiehls Dermatologist Solutions Better Screen UV Serum Broad Spectrum SPF 50 Plus Sunscreen2 mL in 1 PACKETLOTION23
49967-053-04Kiehls Dermatologist Solutions Better Screen UV Serum Broad Spectrum SPF 50 Plus Sunscreen1 in 1 CARTONLOTION13
49967-053-04Kiehls Dermatologist Solutions Better Screen UV Serum Broad Spectrum SPF 50 Plus Sunscreen100 mL in 1 BOTTLELOTION1003

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-05349967-053-01, 49967-053-02, 49967-053-03, 49967-053-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

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 Dermatologist Solutions Better Screen UV Serum Broad Spectrum SPF 50 Plus SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc48980ef3-ebda-450e-9f15-effad27dec9a2025-07-11WarningsExact identifier
ndc (package): 49967-053-04
ndc (package): 49967-053-03
ndc (package): 49967-053-02
ndc (package): 49967-053-01
ndc (product): 49967-053
ndc11 (package): 49967005302
ndc11 (package): 49967005301
ndc11 (package): 49967005303
ndc11 (package): 49967005304
spl id: 2d2e8d69-d4ee-4152-8076-a6cfe5ac48f1
spl set id: 48980ef3-ebda-450e-9f15-effad27dec9a

Reported adverse events (FAERS/openFDA)#

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