Drug Facts

Manufacturer
L'Oreal USA Products Inc | Dimensional Merchandising Inc.
Effective date
2023-12-30
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:06:09

Label at a glance#

ProductKiehls Since 1851 Dermatologist Solutions SuperFluid UV Mineral Defense Broad Spectrum SPF 50 Plus Sunscreen
Active ingredientTITANIUM DIOXIDE
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: 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 ...

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

Titanium dioxide 15%

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:

  • 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. – 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, isododecane, dimethicone, C12-15 alkyl benzoate, undecane, styrene/acrylates copolymer, caprylyl methicone, nylon-12, butyloctyl salicylate, phenethyl benzoate, dicaprylyl carbonate, silica, triethylhexanoin, isohexadecane, tridecane, dicaprylyl ether, talc, dimethicone/PEG-10/15 crosspolymer, aluminum hydroxide, stearic acid, pentylene glycol, PEG-9 polydimethylsiloxyethyl dimethicone, iron oxides, aluminum stearate, PEG-8 laurate, phenoxyethanol, magnesium sulfate, caprylyl glycol, alumina, polyhydroxystearic acid, disteardimonium hectorite, tocopherol, propylene carbonate, benzoic acid, disodium stearoyl glutamate, PEG-9

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-946-4453

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of a cartronimage of a cartron

image of a cartron
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DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-409-01Kiehls Since 1851 Dermatologist Solutions SuperFluid UV Mineral Defense Broad Spectrum SPF 50 Plus Sunscreen1 in 1 CARTONLOTION17
49967-409-01Kiehls Since 1851 Dermatologist Solutions SuperFluid UV Mineral Defense Broad Spectrum SPF 50 Plus Sunscreen50 mL in 1 TUBELOTION507
49967-409-02Kiehls Since 1851 Dermatologist Solutions SuperFluid UV Mineral Defense Broad Spectrum SPF 50 Plus Sunscreen5 mL in 1 TUBELOTION57
49967-409-02Kiehls Since 1851 Dermatologist Solutions SuperFluid UV Mineral Defense Broad Spectrum SPF 50 Plus Sunscreen1 in 1 CARTONLOTION17
49967-409-03Kiehls Since 1851 Dermatologist Solutions SuperFluid UV Mineral Defense Broad Spectrum SPF 50 Plus Sunscreen1 in 1 CARTONLOTION17
49967-409-03Kiehls Since 1851 Dermatologist Solutions SuperFluid UV Mineral Defense Broad Spectrum SPF 50 Plus Sunscreen50 mL in 1 BOTTLELOTION507
49967-409-04Kiehls Since 1851 Dermatologist Solutions SuperFluid UV Mineral Defense Broad Spectrum SPF 50 Plus Sunscreen1 in 1 CARTONLOTION17
49967-409-04Kiehls Since 1851 Dermatologist Solutions SuperFluid UV Mineral Defense Broad Spectrum SPF 50 Plus Sunscreen5 mL in 1 BOTTLELOTION57

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-409KIEHLS SINCE 1851 DERMATOLOGIST SOLUTIONS SUPERFLUID UV MINERAL DEFENSE BROAD SPECTRUM SPF 50 PLUS SUNSCREEN (TITANIUM DIOXIDE) LOTION [L'OREAL USA PRODUCTS INC]7Current NDC, Legacy NDC, 8 package rows20231231_eb43177e-389d-4572-8521-ee4d0a2dad3a.zip

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-40949967-409-01, 49967-409-02, 49967-409-03, 49967-409-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 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 Since 1851 Dermatologist Solutions SuperFluid UV Mineral Defense Broad Spectrum SPF 50 Plus SunscreenTITANIUM DIOXIDEL'Oreal USA Products Inceb43177e-389d-4572-8521-ee4d0a2dad3a2023-12-30WarningsExact identifier
ndc (package): 49967-409-04
ndc (package): 49967-409-02
ndc (package): 49967-409-01
ndc (package): 49967-409-03
ndc (product): 49967-409
ndc11 (package): 49967040902
ndc11 (package): 49967040901
ndc11 (package): 49967040904
ndc11 (package): 49967040903
spl id: 9c24442b-9868-4269-b783-419171eda036
spl set id: eb43177e-389d-4572-8521-ee4d0a2dad3a

Reported adverse events (FAERS/openFDA)#

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