OTC - ACTIVE INGREDIENT SECTION
Octinoxate 2.0%
Titanium Dioxide 2.5%
Octinoxate 2.0%
Titanium Dioxide 2.5%
Sunscreen
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Helps prevent sunburn.
Skin cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.
For sunscreen use:
water, cyclopentasiloxane, neopentyl, glycol diethylhexanoate, butylene glycol, hdi/trimethylol hexyllactone crosspolymer, mica, glycern, vinyl dimethicone/methicone silsesquioxane crosspolymer, peg-10 dimethicone, caprylic/capric triglyceride, disteardimonium hectorite, phenoxyethanol, methyl methacrylate crosspolymer, caprylyl glycol, aluminum dimyristate, triethoxycaprylylsilane, parfum/fragrance, retinyl palmitate, sodium hyaluronate, tocopheryl acetate, silica, disodium stearoyl glutamate, ascorbyl glucoside, sorbic acid, alaria esculenta extract, tocopherol, bht, may contain: iron oxides.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 66184-400-01 | 2019-11-13 | C162847 | 48780-1 | 97449f38-ba62-f6ea-e053-dbdaa90aa703 | Drug Facts |
| 66184-400-02 | 2019-11-13 | C162847 | 48780-1 | 97449f38-ba62-f6ea-e053-dbdaa90aa703 | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66184-400-01 | ck one3-in-1face makeupwith SPF8 sunscreen | 30 mL in 1 CONTAINER | LIQUID | 30 | 1 | |
| 66184-400-02 | ck one3-in-1face makeupwith SPF8 sunscreen | 30 mL in 1 BOX | LIQUID | 30 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Octinoxate | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| Titanium Dioxide | ACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| Octinoxate | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| Titanium Dioxide | ACTIVE MOIETY | 15FIX9V2JP | 1 | |
| Alaria Esculenta | INACTIVE INGREDIENT | EJ9JK8J58D | 1 | |
| Alpha-Tocopherol Acetate | INACTIVE INGREDIENT | 9E8X80D2L0 | 1 | |
| Aluminum Dimyristate | INACTIVE INGREDIENT | J2KA067N9O | 1 | |
| Butylated Hydroxytoluene | INACTIVE INGREDIENT | 1P9D0Z171K | 1 | |
| Butylene Glycol | INACTIVE INGREDIENT | 3XUS85K0RA | 1 | |
| Caprylyl Glycol | INACTIVE INGREDIENT | 00YIU5438U | 1 | |
| Cyclomethicone 5 | INACTIVE INGREDIENT | 0THT5PCI0R | 1 | |
| Disodium Stearoyl Glutamate | INACTIVE INGREDIENT | 45ASM2L11M | 1 | |
| Hyaluronate Sodium | INACTIVE INGREDIENT | YSE9PPT4TH | 1 | |
| Methyl Methacrylate | INACTIVE INGREDIENT | 196OC77688 | 1 | |
| Neopentyl Glycol | INACTIVE INGREDIENT | QI80HXD6S5 | 1 | |
| PEG-10 DIMETHICONE (600 CST) | INACTIVE INGREDIENT | 8PR7V1SVM0 | 1 | |
| Phenoxyethanol | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| Silicon Dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| Sorbic Acid | INACTIVE INGREDIENT | X045WJ989B | 1 | |
| Tocopherol | INACTIVE INGREDIENT | R0ZB2556P8 | 1 | |
| Tricaprin | INACTIVE INGREDIENT | O1PB8EU98M | 1 | |
| Triethoxycaprylylsilane | INACTIVE INGREDIENT | LDC331P08E | 1 | |
| Vitamin A Palmitate | INACTIVE INGREDIENT | 1D1K0N0VVC | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 66184-400 | 66184-400-01, 66184-400-02 |
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 |
|---|---|---|---|---|---|---|
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE / ORAL | 5000 mg | ||
| Cyclomethicone 5 | CYCLOMETHICONE 5 | 0THT5PCI0R | AEROSOL / TOPICAL | 2.5 %w/w | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, COATED / ORAL | 176 mg | ||
| Butylated Hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CREAM, AUGMENTED / TOPICAL | 0.2 %w/w | ||
| Butylated Hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | INJECTION / INTRAVENOUS | NA | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | LOZENGE / ORAL | 120 mg | ||
| Sorbic Acid | SORBIC ACID | X045WJ989B | TABLET, COATED / ORAL | 1 mg | ||
| Sorbic Acid | SORBIC ACID | X045WJ989B | LOTION / TOPICAL | 4 mg | ||
| Butylated Hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SOLUTION, CONCENTRATE / ORAL | 0.1 mg/1ml | ||
| Sorbic Acid | SORBIC ACID | X045WJ989B | EMULSION / OPHTHALMIC | 1 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | SYSTEM / TRANSDERMAL | 35 mg | ||
| Hyaluronate Sodium | HYALURONATE SODIUM | YSE9PPT4TH | INJECTION, SUSPENSION / INTRAVITREAL | 23 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| Butylated Hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CAPSULE, EXTENDED RELEASE / ORAL | 0.03 mg | ||
| Butylated Hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SWAB / TOPICAL | 0.5 %w/w | ||
| Sorbic Acid | SORBIC ACID | X045WJ989B | SYRUP / ORAL | 80 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / RESPIRATORY (INHALATION) | NA | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED PELLETS / ORAL | 69 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, LIQUID FILLED / ORAL | 106 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 69 mg | ||
| Sorbic Acid | SORBIC ACID | X045WJ989B | TABLET / SUBLINGUAL | 0.16 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| Sorbic Acid | SORBIC ACID | X045WJ989B | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 1 mg | ||
| Butylated Hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CAPSULE / ORAL | 3 mg | ||
| Cyclomethicone 5 | CYCLOMETHICONE 5 | 0THT5PCI0R | AEROSOL, FOAM / TOPICAL | 144 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 2 mg | ||
| Butylated Hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SHAMPOO / TOPICAL | 0.1 %w/w | ||
| Butylated Hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SPRAY / TOPICAL | 3 mg | ||
| Butylated Hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 0.02 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CREAM / VAGINAL | 51 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION, EXTENDED RELEASE / ORAL | 70 mg | ||
| Alpha-Tocopherol Acetate | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | TABLET / ORAL | 0.5 mg | ||
| Butylated Hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | GEL / TOPICAL | 8 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, DELAYED RELEASE / ORAL | 3.2 mg | ||
| Hyaluronate Sodium | HYALURONATE SODIUM | YSE9PPT4TH | INJECTION, SUSPENSION / INTRA-ARTICULAR | 23 mg | ||
| Sorbic Acid | SORBIC ACID | X045WJ989B | SUSPENSION / ORAL | 40 mg | ||
| Butylated Hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SOLUTION / ORAL | 14 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | DROPS / ORAL | NA | ||
| Tocopherol | TOCOPHEROL | R0ZB2556P8 | TABLET / ORAL | 0.08 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | PASTE / DENTAL | 34 %w/w | ||
| Sorbic Acid | SORBIC ACID | X045WJ989B | SOLUTION / OPHTHALMIC | 0.2 %w/v | ||
| Sorbic Acid | SORBIC ACID | X045WJ989B | CONCENTRATE / ORAL | 1 mg | ||
| Tocopherol | TOCOPHEROL | R0ZB2556P8 | CREAM / TOPICAL | NA | ||
| Butylated Hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SPRAY, METERED / NASAL | 0.1 mg/1ml | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SOLUTION / ORAL | 280 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, EXTENDED RELEASE / ORAL | 450 mg | ||
| Butylene Glycol | BUTYLENE GLYCOL | 3XUS85K0RA | SYSTEM / TRANSDERMAL | 8.12 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / ORAL | 300 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED / ORAL | 3 mg | ||
| Butylated Hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | TABLET / SUBLINGUAL | 0.13 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 336 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TAMPON / VAGINAL | NA | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / BUCCAL | 3 mg | ||
| Butylated Hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | OINTMENT / TOPICAL | 57 mg | ||
| Butylated Hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | FILM, SOLUBLE / ORAL | 0.06 mg | ||
| Hyaluronate Sodium | HYALURONATE SODIUM | YSE9PPT4TH | LOTION / TOPICAL | 0.01 %w/w | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / TOPICAL | 6 mg | ||
| Sorbic Acid | SORBIC ACID | X045WJ989B | SOLUTION / ORAL | 80 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 |
|---|---|---|---|---|---|---|
| e71e7dfa-968d-4619-9932-4fa2b7ef6519 | 9b905703-6fc9-4661-8edd-40bbdf3a3951 | 2011-12-07 | Warnings | e71e7dfa-968d-4619-9932-4fa2b7ef6519 9b905703-6fc9-4661-8edd-40bbdf3a3951 |
Adverse event summaries are temporarily unavailable. Other product information remains available.