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.
octocrylene, octinoxate, octisalate, titanium dioxide, ensulizole
- Manufacturer
- Biocosmetica Exel Argentina SRL
- Effective date
- 2025-01-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 00:52:26
Label at a glance#
ProductEXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WHITE COLOR BROAD SPECTRUM SPF 60 PLUS
Active ingredientENSULIZOLE, OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, OCTISALATE
Label structure9 sections
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 the sun, especial...
Label contents#
Full prescribing information#
Active ingredients , purpose
Octocrylene 10%, sunscreen
Octinoxate 5%, sunscreen
Octisalate 5%, sunscreen
Titanium dioxide 5%, sunscreen
Ensulizole 4 %, sunscreen
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.
Warnings
For external use only. Do not swallow.
If swallowed, get medical help or contact a Poison Control Center right away.
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 reach of children .
This product is not formulated for use in children.
Directions
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 AM-2 PM
Wear long-sleeved shirts, pants, hats and sunglasses.
Children under 6 months of age: ask a doctor.
Inactive Ingredients
BISABOLOL, BUTYROSPERMUM PARKII BUTTER, CALCIUM DISODIUM EDTA, CAMELLIA SINENSIS LEAF EXTRACT, CAPRYLIC/CAPRIC TRIGLYCERIDE, CAPRYLYL GLYCOL, CARBOMER, CETEARETH-20, CETEARYL ALCOHOL, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, GLYCERYL STEARATE S.E., HYDROGENATED PHOSPHATIDYLCHOLINE, LINOLEIC ACID, PALMITOYL PENTAPEPTIDE-4, PHENOXYETHANOL, PHOSPHOLIPIDS, POLYPODIUM LEUCOTOMOS LEAF EXTRACT, POLYSORBATE 20, PROPANEDIOL, SODIUM ASCORBYL PHOSPHATE, SODIUM HYALURONATE, TOCOPHERYL ACETATE, WATER (AQUA), XANTHAN GUM
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
DOSAGE & ADMINISTRATION SECTION
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INDICATIONS & USAGE SECTION
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67623-004-01 | EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WHITE COLOR BROAD SPECTRUM SPF 60 PLUS | 100 mL in 1 TUBE | CREAM | 100 | 1 | |
| 67623-004-01 | EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WHITE COLOR BROAD SPECTRUM SPF 60 PLUS | 1 in 1 CARTON | CREAM | 1 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 67623-004 | EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WHITE COLOR BROAD SPECTRUM SPF 60 PLUS (OCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLE) CREAM [BIOCOSMETICA EXEL ARGENTINA SRL] | 1 | Current NDC, 2 package rows | 20250113_2aabf782-65f9-e894-e063-6394a90a1ea3.zip |
Products#
Every source-derived product name is available through these pages.
- EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WHITE COLOR BROAD SPECTRUM SPF 60 PLUS
- octocrylene, octinoxate, octisalate, titanium dioxide, ensulizole
- LINOLEIC ACID
- WATER
- BISABOLOL
- DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE
- ENSULIZOLE
- LECITHIN, SOYBEAN
- PHLEBODIUM AUREUM LEAF
- PHENOXYETHANOL
- OCTINOXATE
- PALMITOYL PENTAPEPTIDE-4
- CAMELLIA SINENSIS LEAF
- PROPANEDIOL
- SODIUM HYALURONATE
- OCTOCRYLENE
- TITANIUM DIOXIDE
- CARBOMER INTERPOLYMER TYPE A (55000 CPS)
- BUTYROSPERMUM PARKII (SHEA) BUTTER
- CAPRYLYL GLYCOL
- SODIUM ASCORBYL PHOSPHATE
- CALCIUM DISODIUM EDTA
- OCTISALATE
- CAPRYLIC/CAPRIC TRIGLYCERIDE
- CETEARETH-20
- CETEARYL ALCOHOL
- HYDROGENATED SOYBEAN PHOSPHATIDYLCHOLINE
- POLYSORBATE 20
- XANTHAN GUM
- GLYCERYL STEARATE SE
- ALPHA-TOCOPHEROL ACETATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 67623-004 | 67623-004-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WHITE COLOR BROAD SPECTRUM SPF 60 PLUS | OCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLE | Biocosmetica Exel Argentina SRL | 2aabf782-65f9-e894-e063-6394a90a1ea3 | 2025-01-01 | Warnings | 67623-004-01 67623-004 67623000401 2aabf782-65fa-e894-e063-6394a90a1ea3 2aabf782-65f9-e894-e063-6394a90a1ea3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.