FDA.reportPublic FDA data

Exel Clarifying Line

Manufacturer
Biocosmetica Exel Argentina SRL
Effective date
2024-06-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:14:49

Label at a glance#

ProductExel Clarifying Line SPF 50
Active ingredientOCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient ........ Purpose

Octinoxate 7.5% ........ Sunscreen
Octocrylene 8% ........ Sunscreen

Oxybenzone 3% ........ Sunscreen

Titanium Dioxide 5% ........ Sunscreen

OTC - PURPOSE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs

DOSAGE & ADMINISTRATION SECTION

Directions

- Apply liberally 15 minutes before sun exposure

- Reapply at least every 2 hours

- Children under 6 month: ask a doctor

-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 AM - 2 PMWear long-sleeved shirts, pants, hats, and sunglassesUse a water resistant sunscreen if swimming or sweating

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, BHT, Butyrospermum Parkii (shea butter) Extract, Calcium Disodium EDTA, Caprylic/Capric Triglyceride, Cetearyl Alcohol (and) Ceteareth-20, Cyclomethicone, Cyclopentasiloxane, Diethlyamino Hydroxybenzoyl Hexyl Benzoate, Dimethicone, DMDM Hydantoin, Ectoin, Fragrance (Parfum), Glyceryl Stearate SE, Hamamelis Virginiana (witch hazel) Extract, Iron Oxides (C.I. 77497/77492/77499), Phenoxyethanol, Polysorbate 20, Propylene Glycol, Sodium DNA, Tocopheryl Acetate, Water (Aqua), Xanthan Gum, Yeast Extract (saccharomyces cerevisiae extract)  

WARNINGS

WARNINGS SECTION

For external use only.

Do not use on damaged or broken skin.

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

Stop use and ask a doctor if rash occurs.

Keep out of children . If swallowed get medical help or contact a Poison Control Center right away.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Exel Clarifying Line
SPF 50
Broad Spectrum SPF 50

3.30 fl.oz / 100 ml

Clarifying line label updateClarifying line label update

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67623-001-022023-04-12C16284748780-1f386c649-e028-0266-e053-dadaa90a7c1aExel Clarifying Line SPF 50
67623-001-022023-01-30C16284748780-1f386c649-e028-0266-e053-dadaa90a7c1aExel Clarifying Line SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67623-001-01Exel Clarifying LineSPF 50100 mL in 1 TUBECREAM1004
67623-001-02Exel Clarifying LineSPF 501 in 1 PACKAGECREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67623-001EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [BIOCOSMETICA EXEL ARGENTINA SRL]4Current NDC, Legacy NDC, 2 package rows20240708_e65a68f6-d1b7-4cbf-a3f8-5cc04036221a.zip

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67623-00167623-001-01, 67623-001-02

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
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
ALOE VERA LEAFZY81Z83H0XIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
SHEANUT OILO88E196QRFIACT
EDETATE CALCIUM DISODIUM ANHYDROUS8U5D034955IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CYCLOMETHICONENMQ347994ZIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATEANQ870JD20IACT
DIMETHICONE92RU3N3Y1OIACT
DMDM HYDANTOINBYR0546TOWIACT
ECTOINE7GXZ3858RYIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
HAMAMELIS VIRGINIANA TOPUDA30A2JJYIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
YEAST, UNSPECIFIED3NY3SM6B8UIACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB

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
Exel Clarifying Line SPF 50OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDEBiocosmetica Exel Argentina SRLe65a68f6-d1b7-4cbf-a3f8-5cc04036221a2024-06-23WarningsExact identifier
ndc (package): 67623-001-01
ndc (package): 67623-001-02
ndc (product): 67623-001
ndc11 (package): 67623000101
ndc11 (package): 67623000102
spl id: 1b9444d4-edaa-7291-e063-6394a90a25d3
spl set id: e65a68f6-d1b7-4cbf-a3f8-5cc04036221a

Reported adverse events (FAERS/openFDA)#

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