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Drug Facts

Manufacturer
L'Oreal USA Products Inc | Beauty Manufacturing Solutions Corp.
Effective date
2024-07-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:15:19

Label at a glance#

ProductSkinCeuticals Clear Daily Soothing UV Defense Daily Sunscreen Broad Spectrum SPF 50
Active ingredientHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE
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

● 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 th...

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

Homosalate 8%

Octisalate 5%

Octocrylene 5%

Zinc oxide 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

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

● 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, glycerin, coco-caprylate/caprate, propanediol, butyloctyl salicylate, steareth-20, c12-22 alkyl acrylate/hydroxyethylacrylate copolymer, ethylhexyl methoxycrylene, oryza sativa (rice) bran wax, butylene glycol, steareth-2, bisabolol, hydroxyacetophenone, polyhydroxystearic acid, diethylhexyl syringylidenemalonate, chlorphenesin, caprylyl glycol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, citric acid, xanthan gum, triethoxycaprylylsilane, trisodium ethylenediamine disuccinate, caprylic/capric triglyceride, sorbitan isostearate, polysorbate 60, palmitoyl tripeptide-8, dextran

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-811-1660

Monday - Friday (9 a.m. - 5 p.m. CST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of a cartonimage of a cartonimage of a cartonimage of a carton

image of a carton
image of a carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-992-01SkinCeuticals Clear Daily Soothing UV Defense Daily Sunscreen Broad Spectrum SPF 5030 mL in 1 JARLOTION301
49967-992-01SkinCeuticals Clear Daily Soothing UV Defense Daily Sunscreen Broad Spectrum SPF 501 in 1 CARTONLOTION11
49967-992-02SkinCeuticals Clear Daily Soothing UV Defense Daily Sunscreen Broad Spectrum SPF 504 mL in 1 TUBELOTION41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-992SKINCEUTICALS CLEAR DAILY SOOTHING UV DEFENSE DAILY SUNSCREEN BROAD SPECTRUM SPF 50 (HOMOSALATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDE) LOTION [L'OREAL USA PRODUCTS INC]1Current NDC, 3 package rows20240716_817c882d-72f3-4ee7-8da2-a4a32f9d167f.zip

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-99249967-992-01, 49967-992-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
ZINC OXIDESOI2LOH54ZACTIM
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
PROPANEDIOL5965N8W85TIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
STEARETH-20L0Q8IK9E08IACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
RICE BRANR60QEP13ICIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
STEARETH-2V56DFE46J5IACT
LEVOMENOL24WE03BX2TIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
DIETHYLHEXYL SYRINGYLIDENEMALONATE3V5U97P248IACT
CHLORPHENESINI670DAL4SZIACT
CAPRYLYL GLYCOL00YIU5438UIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
XANTHAN GUMTTV12P4NEEIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
POLYSORBATE 60CAL22UVI4MIACT
PALMITOYL TRIPEPTIDE-855HZC7YQA7IACT
DEXTRAN 40K3R6ZDH4DUIACT

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
SkinCeuticals Clear Daily Soothing UV Defense Daily Sunscreen Broad Spectrum SPF 50HOMOSALATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDEL'Oreal USA Products Inc817c882d-72f3-4ee7-8da2-a4a32f9d167f2024-07-14WarningsExact identifier
ndc (package): 49967-992-01
ndc (package): 49967-992-02
ndc (product): 49967-992
ndc11 (package): 49967099202
ndc11 (package): 49967099201
spl id: ea4a7d45-6c3e-497f-b5c1-0a498b1daf48
spl set id: 817c882d-72f3-4ee7-8da2-a4a32f9d167f

Reported adverse events (FAERS/openFDA)#

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