OTC - ACTIVE INGREDIENT SECTION
OCTINOXATE (5%)
Provides high protection against sunburn and tanning.
Discontinue use if sign of irritation or rash appear.
Dispense an adequate amount and apply evenly. (At the final stage of basic skincare, dispense an adequate amount and apply evenly to desired parts)
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 51523-106-02 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-ceae-8e05-e053-dbdaa90a074a | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51523-106-01 | FACE IT AQUA TINTED BB SPF 20 PA 02 | 40 mL in 1 CONTAINER | CREAM | 40 | 2 | |
| 51523-106-02 | FACE IT AQUA TINTED BB SPF 20 PA 02 | 1 in 1 BOX | CREAM | 1 | 2 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 2 | |
| TITANIUM DIOXIDE | ACTIVE INGREDIENT | 15FIX9V2JP | 2 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 2 | |
| TITANIUM DIOXIDE | ACTIVE MOIETY | 15FIX9V2JP | 2 | |
| BIOSACCHARIDE GUM-1 | INACTIVE INGREDIENT | BB4PU4V09H | 2 | |
| BUTYLENE GLYCOL | INACTIVE INGREDIENT | 3XUS85K0RA | 2 | |
| CYCLOMETHICONE 5 | INACTIVE INGREDIENT | 0THT5PCI0R | 2 | |
| ETHYLPARABEN | INACTIVE INGREDIENT | 14255EXE39 | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 2 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 2 | |
| HEXYL LAURATE | INACTIVE INGREDIENT | 4CG9F9W01Q | 2 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 2 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 2 | |
| POLYSORBATE 60 | INACTIVE INGREDIENT | CAL22UVI4M | 2 | |
| PONCIRUS TRIFOLIATA FRUIT | INACTIVE INGREDIENT | 44445L49J2 | 2 | |
| SQUALANE | INACTIVE INGREDIENT | GW89575KF9 | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 2 | |
| TRIETHOXYCAPRYLYLSILANE | INACTIVE INGREDIENT | LDC331P08E | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 51523-106 | 51523-106-01, 51523-106-02 |
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 |
|---|---|---|---|---|---|---|
| TALC | TALC | 7SEV7J4R1U | PELLET / ORAL | 69 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / IRRIGATION | 2 %w/v | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET / ORAL | 2 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | GEL / TOPICAL | 24 mg | ||
| SQUALANE | SQUALANE | GW89575KF9 | CREAM, AUGMENTED / TOPICAL | 120 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, EXTENDED RELEASE / ORAL | 5 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | GRANULE, FOR SUSPENSION / ORAL | 80 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / DENTAL | 15 %w/v | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 3.6 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | JELLY / TOPICAL | 420 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TRANSDERMAL | 500 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, COATED / ORAL | 1 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, EXTENDED RELEASE / ORAL | 5119 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, CHEWABLE / ORAL | 202 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, COATED / ORAL | 320.75 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUPPOSITORY / VAGINAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | JELLY / VAGINAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION, EXTENDED RELEASE / ORAL | 2000 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 225 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / RECTAL | 0.13 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CREAM, AUGMENTED / TOPICAL | 2 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, DELAYED RELEASE / ORAL | 6 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY, METERED / NASAL | 13 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / TOPICAL | 1971 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | FILM / BUCCAL | 1 mg | ||
| TALC | TALC | 7SEV7J4R1U | GRANULE, DELAYED RELEASE / ORAL | 525 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SHAMPOO, SUSPENSION / TOPICAL | 0.15 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | LIQUID / ORAL | 162 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | GEL / VAGINAL | 8 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / ORAL | 388 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 2 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, DELAYED RELEASE / ORAL | 420 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / AURICULAR (OTIC) | 0.05 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DROPS / NASAL | 10 mg/1ml | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, COATED / ORAL | 0.12 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / AURICULAR (OTIC) | 25 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| SQUALANE | SQUALANE | GW89575KF9 | CREAM / TOPICAL | 6 %w/w | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, EXTENDED RELEASE / ORAL | 8 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, EXTENDED RELEASE / ORAL | 15 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | POWDER, FOR SUSPENSION / ORAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / SUBCUTANEOUS | 22 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SHAMPOO / TOPICAL | 0.15 %w/w | ||
| SQUALANE | SQUALANE | GW89575KF9 | SOLUTION / TOPICAL | 1 %w/w | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / ORAL | 1000 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, EMULSION / INTRAVENOUS | 24100 mg | ||
| TALC | TALC | 7SEV7J4R1U | LOZENGE / ORAL | 50 mg | ||
| SQUALANE | SQUALANE | GW89575KF9 | POWDER / ORAL | 0.02 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CAPSULE, EXTENDED RELEASE / ORAL | 2 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | PASTE, DENTIFRICE / DENTAL | 0.05 %w/w | ||
| TALC | TALC | 7SEV7J4R1U | DROPS / ORAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / AURICULAR (OTIC) | 0.01 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / IONTOPHORESIS | 168.1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / INTRAVENOUS | 45 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAVENOUS | 15 %w/v |
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 |
|---|---|---|---|---|---|---|
| 0d7fea65-9b75-4cac-896f-3fd0753db2bf | 0da4a8a4-7547-4d0b-97d9-aace17026ce5 | 2011-09-01 | 0d7fea65-9b75-4cac-896f-3fd0753db2bf 0da4a8a4-7547-4d0b-97d9-aace17026ce5 |
Adverse event summaries are temporarily unavailable. Other product information remains available.