FDA.reportPublic FDA data

LA MER THE RADIANT SKINTINT BROAD SPECTRUM SPF 30

Manufacturer
MAX HUBER RESEARCH LAB INC | Estee Lauder Companies Inc. | Estee Lauder N.V.
Effective date
2023-10-30
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 23:58:28

Label at a glance#

ProductLA MER THE RADIANT SKINTINT BROAD SPECTRUM SPF 30
Active ingredientOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE
Label structure9 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 at least every two 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...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

OCTINOXATE 7.5%
OCTISALATE 2.0%
TITANIUM DIOXIDE 5.3%

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

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is 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 at least every two 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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

WATER\AQUA\EAU • BUTYLENE GLYCOL • OCTYLDODECYL NEOPENTANOATE • CETYL ALCOHOL • LAURETH-4 • ASCORBYL GLUCOSIDE • NEOPENTYL GLYCOL DIHEPTANOATE • ALGAE (SEAWEED) EXTRACT • SESAMUM INDICUM (SESAME) SEED OIL • MEDICAGO SATIVA (ALFALFA) SEED POWDER • HELIANTHUS ANNUUS (SUNFLOWER) SEEDCAKE • PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) SEED MEAL • EUCALYPTUS GLOBULUS (EUCALYPTUS) LEAF OIL • SODIUM GLUCONATE • COPPER GLUCONATE • CALCIUM GLUCONATE • MAGNESIUM GLUCONATE • ZINC GLUCONATE • TOCOPHERYL SUCCINATE • NIACIN • SESAMUM INDICUM (SESAME) SEED POWDER • POLYETHYLENE • HELICHRYSUM ARENARIUM (EVERLASTING) EXTRACT • CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT • PEG-100 STEARATE • HYDROGENATED LECITHIN • CORALLINA OFFICINALIS EXTRACT • GELIDIUM CARTILAGINEUM EXTRACT • SACCHAROMYCES LYSATE EXTRACT • MENTHA VIRIDIS (SPEARMINT) • PELARGONIUM GRAVEOLENS (GERANIUM) FLOWER OIL • LAMINARIA SACCHARINA EXTRACT • CITRUS GRANDIS (GRAPEFRUIT) PEEL OIL • LAMINARIA DIGITATA EXTRACT • METHYLDIHYDROJASMONATE • SIGESBECKIA ORIENTALIS (ST. PAUL'S WORT) EXTRACT • ACETYL HEXAPEPTIDE-8 • SUCROSE • GLYCERIN • GLYCYRRHETINIC ACID • CAFFEINE • PROPYLENE GLYCOL DIETHYLHEXANOATE • LECITHIN • ISOHEXADECANE • POLYGLYCERYL-3 BEESWAX • WHEY PROTEIN\LACTIS PROTEIN\PROTEINE DU PETIT-LAIT • DIMETHOXYTOLYL PROPYLRESORCINOL • CITRUS AURANTIFOLIA (LIME) PEEL EXTRACT • ACETYL GLUCOSAMINE • PVP/HEXADECENE COPOLYMER • TOURMALINE • YEAST POLYSACCHARIDES • CAPRYLYL GLYCOL • ROSA DAMASCENA (ROSE) FLOWER OIL • YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE • ISOSTEARIC ACID • PROPYLENE GLYCOL DICAPRATE • HORDEUM VULGARE (BARLEY) EXTRACT\EXTRAIT D'ORGE • STEARIC ACID • TROMETHAMINE • ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER • GALACTOARABINAN • NYLON-12 • ZEOLITE • SYNTHETIC FLUORPHLOGOPITE • TOCOPHERYL LINOLEATE/OLEATE • SODIUM HYALURONATE • BORON NITRIDE • XANTHAN GUM • POLYSORBATE 80 • SILICA • ALUMINUM HYDROXIDE • ALCOHOL DENAT. • TIN OXIDE • DISODIUM EDTA • BHT • LINALOOL • GERANIOL • CITRONELLOL • LIMONENE • PHENOXYETHANOL • [+/- TITANIUM DIOXIDE (CI 77891) • IRON OXIDES (CI 77491) • IRON OXIDES (CI 77492) • IRON OXIDES (CI 77499) • MICA] <ILN45014>

Other information

STORAGE AND HANDLING SECTION

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

PRINCIPAL DISPLAY PANEL - 40 ml Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SKINCOLOR DE LA MER™

LA MER

THE RADIANT SKINTINT
BROAD SPECTRUM SPF 30

1.4 fl. oz. liq. /40 ml e

PRINCIPAL DISPLAY PANEL - 40 ml Tube Carton
PRINCIPAL DISPLAY PANEL - 40 ml Tube Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65966-021-012022-08-04C16284748780-1c7ccaba7-2853-fd44-e053-dadaa90aa01bLA MER THE RADIANT SKINTINT BROAD SPECTRUM SPF 30
65966-021-012022-07-29C16284748780-1c7ccaba7-2853-fd44-e053-dadaa90aa01bLA MER THE RADIANT SKINTINT BROAD SPECTRUM SPF 30
65966-021-012021-07-26C16284748780-1c7ccaba7-2853-fd44-e053-dadaa90aa01bLA MER THE RADIANT SKINTINT BROAD SPECTRUM SPF 30
65966-021-012021-07-23C16284748780-1c7ccaba7-2853-fd44-e053-dadaa90aa01bLA MER THE RADIANT SKINTINT BROAD SPECTRUM SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65966-021-01LA MER THE RADIANT SKINTINT BROAD SPECTRUM SPF 3040 mL in 1 TUBECREAM408
65966-021-01LA MER THE RADIANT SKINTINT BROAD SPECTRUM SPF 301 in 1 CARTONCREAM18
65966-021-02LA MER THE RADIANT SKINTINT BROAD SPECTRUM SPF 303 mL in 1 PACKETCREAM38

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65966-021LA MER THE RADIANT SKINTINT BROAD SPECTRUM SPF 30 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [MAX HUBER RESEARCH LAB INC]8Current NDC, Legacy NDC, 3 package rows20231031_ecc942c7-5495-43b1-9ffa-d38be7891152.zip

Products#

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

DailyMed product names page 1 of 2 · 78 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65966-02165966-021-01, 65966-021-02

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 76 matching rows.

Name, UNII, Kind table
NameUNIIKind
EUCALYPTUS GUM72T9EZC2VXIACT
SODIUM GLUCONATER6Q3791S76IACT
COPPER GLUCONATERV823G6G67IACT
CALCIUM GLUCONATESQE6VB453KIACT
MAGNESIUM GLUCONATET42NAD2KHCIACT
ZINC GLUCONATEU6WSN5SQ1ZIACT
.ALPHA.-TOCOPHEROL SUCCINATE, D-LU4B53JYVEIACT
WATER059QF0KO0RIACT
NIACIN2679MF687AIACT
SESAME SEED7Y1255HVXRIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
GAMOCHAETA PURPUREA FLOWERKQV867ADR4IACT
CUCUMBERYY7C30VXJTIACT
PEG-100 STEARATEYD01N1999RIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
CORALLINA OFFICINALIS4004498D06IACT
PLOCAMIUM CARTILAGINEUM37LBZ0E1UEIACT
SACCHAROMYCES LYSATER85W246Z1CIACT
SPEARMINTJ7I2T6IV1NIACT
PELARGONIUM GRAVEOLENS FLOWER OIL3K0J1S7QGCIACT
SACCHARINA LATISSIMA68CMP2MB55IACT
CITRUS MAXIMA FRUIT RIND OIL8U3877WD44IACT
LAMINARIA DIGITATA15E7C67EE8IACT
METHYL DIHYDROJASMONATE (SYNTHETIC)3GW44CIE3YIACT
ACETYL HEXAPEPTIDE-8L4EL31FWILIACT
SUCROSEC151H8M554IACT
GLYCERINPDC6A3C0OXIACT
ENOXOLONEP540XA09DRIACT
CAFFEINE3G6A5W338EIACT
PROPYLENE GLYCOL DIETHYLHEXANOATE8D8I9Z0F1ZIACT
ISOHEXADECANE918X1OUF1EIACT
DIMETHOXYTOLYL PROPYLRESORCINOL4OD5GIH1UKIACT
LIME PEEL544EQK5Q0WIACT
N-ACETYLGLUCOSAMINEV956696549IACT
CAPRYLYL GLYCOL00YIU5438UIACT
ROSA X DAMASCENA FLOWER OIL18920M3T13IACT
YEAST, UNSPECIFIED3NY3SM6B8UIACT
ISOSTEARIC ACIDX33R8U0062IACT
PROPYLENE GLYCOL DICAPRATEU783H9JHWYIACT
BARLEY5PWM7YLI7RIACT

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
LA MER THE RADIANT SKINTINT BROAD SPECTRUM SPF 30OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDEMAX HUBER RESEARCH LAB INCecc942c7-5495-43b1-9ffa-d38be78911522023-10-30WarningsExact identifier
ndc (package): 65966-021-02
ndc (package): 65966-021-01
ndc (product): 65966-021
ndc11 (package): 65966002102
ndc11 (package): 65966002101
spl id: 08f02263-911e-16e5-e063-6394a90a63f6
spl set id: ecc942c7-5495-43b1-9ffa-d38be7891152

Reported adverse events (FAERS/openFDA)#

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