OTC - ACTIVE INGREDIENT SECTION
Active Ingredient ........ Purpose
Octinoxate 7.5% ........ Sunscreen
Octocrylene 8% ........ Sunscreen
Oxybenzone 3% ........ Sunscreen
Titanium Dioxide 5% ........ Sunscreen
Active Ingredient ........ Purpose
Octinoxate 7.5% ........ Sunscreen
Octocrylene 8% ........ Sunscreen
Oxybenzone 3% ........ Sunscreen
Titanium Dioxide 5% ........ 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
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Stop use and ask a doctor if rash occurs
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
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)
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.
Exel Clarifying Line
SPF 50
Broad Spectrum SPF 50
3.30 fl.oz / 100 ml
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53863-125-02 | 2023-04-12 | C162847 | 48780-1 | f386c649-f075-0266-e053-dadaa90a7c1a | Exel Clarifying Line SPF 50 |
| 53863-125-02 | 2023-01-30 | C162847 | 48780-1 | f386c649-f075-0266-e053-dadaa90a7c1a | Exel Clarifying Line SPF 50 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53863-125-01 | Exel Clarifying LineSPF 50 | 100 mL in 1 TUBE | CREAM | 100 | 8 | |
| 53863-125-02 | Exel Clarifying LineSPF 50 | 1 in 1 PACKAGE | CREAM | 1 | 8 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53863-125 | EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240708_0d6d4098-4121-477e-b404-3ab18628ed68.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 2 | |
| OCTOCRYLENE | ACTIVE INGREDIENT | 5A68WGF6WM | 2 | |
| OXYBENZONE | ACTIVE INGREDIENT | 95OOS7VE0Y | 2 | |
| TITANIUM DIOXIDE | ACTIVE INGREDIENT | 15FIX9V2JP | 2 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 2 | |
| OCTOCRYLENE | ACTIVE MOIETY | 5A68WGF6WM | 2 | |
| OXYBENZONE | ACTIVE MOIETY | 95OOS7VE0Y | 2 | |
| TITANIUM DIOXIDE | ACTIVE MOIETY | 15FIX9V2JP | 2 | |
| .ALPHA.-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 2 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | 2 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | 2 | |
| CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) | INACTIVE INGREDIENT | 59TL3WG5CO | 2 | |
| CETOSTEARYL ALCOHOL | INACTIVE INGREDIENT | 2DMT128M1S | 2 | |
| CYCLOMETHICONE | INACTIVE INGREDIENT | NMQ347994Z | 2 | |
| CYCLOMETHICONE 5 | INACTIVE INGREDIENT | 0THT5PCI0R | 2 | |
| DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE | INACTIVE INGREDIENT | ANQ870JD20 | 2 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 2 | |
| DMDM HYDANTOIN | INACTIVE INGREDIENT | BYR0546TOW | 2 | |
| ECTOINE | INACTIVE INGREDIENT | 7GXZ3858RY | 2 | |
| EDETATE CALCIUM DISODIUM ANHYDROUS | INACTIVE INGREDIENT | 8U5D034955 | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 2 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | 2 | |
| GLYCERYL STEARATE SE | INACTIVE INGREDIENT | FCZ5MH785I | 2 | |
| HAMAMELIS VIRGINIANA TOP | INACTIVE INGREDIENT | UDA30A2JJY | 2 | |
| MEDIUM-CHAIN TRIGLYCERIDES | INACTIVE INGREDIENT | C9H2L21V7U | 2 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 2 | |
| POLYOXYL 20 CETOSTEARYL ETHER | INACTIVE INGREDIENT | YRC528SWUY | 2 | |
| POLYSORBATE 20 | INACTIVE INGREDIENT | 7T1F30V5YH | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 2 | |
| SHEANUT OIL | INACTIVE INGREDIENT | O88E196QRF | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 2 | |
| YEAST, UNSPECIFIED | INACTIVE INGREDIENT | 3NY3SM6B8U | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 53863-125 | 53863-125-01, 53863-125-02 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, EXTENDED RELEASE / ORAL | 15 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, DELAYED RELEASE / ORAL | 3 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, DELAYED RELEASE / ORAL | 6 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | CREAM / TOPICAL | 3300 mg | ||
| DMDM HYDANTOIN | DMDM HYDANTOIN | BYR0546TOW | LOTION / TOPICAL | 3 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / TOPICAL | 76000 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, FILM COATED / ORAL | 6 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, COATED / ORAL | 0.11 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, FILM COATED / ORAL | 0.2 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, FILM COATED / ORAL | 0.2 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, DELAYED RELEASE / ORAL | 7 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET / ORAL | 2 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | POWDER, FOR SUSPENSION / ORAL | NA | ||
| EDETATE CALCIUM DISODIUM ANHYDROUS | EDETATE CALCIUM DISODIUM ANHYDROUS | 8U5D034955 | INJECTION, SOLUTION / INTRAVASCULAR | 0.05 %w/v | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| POLYOXYL 20 CETOSTEARYL ETHER | POLYOXYL 20 CETOSTEARYL ETHER | YRC528SWUY | CREAM / TOPICAL | 180 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, EXTENDED RELEASE / ORAL | 8 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, EXTENDED RELEASE / ORAL | 1.49 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | FILM / BUCCAL | 0.27 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, COATED / ORAL | 0.11 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | CREAM / TOPICAL | 108 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | POWDER, FOR SUSPENSION / ORAL | 3 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET / BUCCAL | 1 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, DELAYED RELEASE / ORAL | 6 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, EXTENDED RELEASE / ORAL | 7 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, DELAYED RELEASE / ORAL | 6 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | CREAM / TOPICAL | 108 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, EXTENDED RELEASE / ORAL | 1.49 mg | ||
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | CREAM / TOPICAL | 1428 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, CHEWABLE / ORAL | 14 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | CREAM / TOPICAL | 46 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | CREAM / TOPICAL | 57 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE / ORAL | 14 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | POWDER, FOR SUSPENSION / ORAL | NA | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, EXTENDED RELEASE / ORAL | 1.49 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET / ORAL | 24 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | CREAM / TOPICAL | 46 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 2 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | SUSPENSION / ORAL | 6 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, EXTENDED RELEASE / ORAL | 8 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | CREAM / TOPICAL | 3300 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, COATED / ORAL | NA | ||
| DMDM HYDANTOIN | DMDM HYDANTOIN | BYR0546TOW | LOTION / TOPICAL | 3 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE / ORAL | 11 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CREAM / TOPICAL | 6 mg | ||
| CYCLOMETHICONE 5 | CYCLOMETHICONE 5 | 0THT5PCI0R | AEROSOL / TOPICAL | 2.5 %w/w | ||
| CYCLOMETHICONE | CYCLOMETHICONE | NMQ347994Z | CREAM / TOPICAL | 13 %w/w | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | GRANULE, FOR SUSPENSION / ORAL | 11 mg | ||
| CYCLOMETHICONE 5 | CYCLOMETHICONE 5 | 0THT5PCI0R | CREAM, AUGMENTED / TOPICAL | 260 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, EXTENDED RELEASE / ORAL | 8 mg | ||
| CYCLOMETHICONE 5 | CYCLOMETHICONE 5 | 0THT5PCI0R | AEROSOL, FOAM / TOPICAL | 144 mg | ||
| .ALPHA.-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | CAPSULE / ORAL | 2 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, DELAYED RELEASE / ORAL | 7 mg | ||
| CYCLOMETHICONE | CYCLOMETHICONE | NMQ347994Z | CREAM / TOPICAL | 13 %w/w | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | POWDER / RESPIRATORY (INHALATION) | 0.04 mg | ||
| EDETATE CALCIUM DISODIUM ANHYDROUS | EDETATE CALCIUM DISODIUM ANHYDROUS | 8U5D034955 | INJECTION / INTRAVENOUS | 23 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | FILM / BUCCAL | 0.27 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | POWDER, FOR SUSPENSION / ORAL | NA | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, EXTENDED RELEASE / ORAL | 15 mg |
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 SPF 50 | OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE | Exelencia importers | 0d6d4098-4121-477e-b404-3ab18628ed68 | 2024-06-30 | Warnings | 53863-125-02 53863-125-01 53863-125 53863012502 53863012501 1c24bf21-f735-0247-e063-6394a90aec30 0d6d4098-4121-477e-b404-3ab18628ed68 |
Adverse event summaries are temporarily unavailable. Other product information remains available.