OTC - ACTIVE INGREDIENT SECTION
Octinoxate 2.5%
Titanium dioxide 5.0%
Octinoxate 2.5%
Titanium dioxide 5.0%
Sunscreen
Keep out of reach children. If swallowed, get medical help or contact a Poison Control Center right away.
Skin cancer/Skin Aging Alert: Spending time int he 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:
aqua/water/eau, hydogentated polyisobutene, isohexadecane, dextrin palmitate, butylene glycol, hydrogenated lecithin, alcohol, triethylhexanoin, quaternium-90, bentonite, pentylene glycol, glycerin, peg-15/lauryl dimethicone crosspolymer, stearoyl inulin, phenoxyethanol, isopropl titanium triisostearate, octyldodectl pca, lysine, isododecane, dipropylene glycol, magnesium chloride, sodium chloride, sodium citrate, may contain: iron oxides, titanium dioxide, mica.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 66184-465-01 | 2019-11-13 | C162847 | 48780-1 | 97449f38-c392-f6ea-e053-dbdaa90aa703 | Drug Facts |
| 66184-465-02 | 2019-11-13 | C162847 | 48780-1 | 97449f38-c392-f6ea-e053-dbdaa90aa703 | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66184-465-01 | ck one waterfresh face makeup spf 15 450 golden | 9.9 g in 1 CARTRIDGE | CREAM | 9.9 | 1 | |
| 66184-465-02 | ck one waterfresh face makeup spf 15 450 golden | 9.9 g in 1 BOX | CREAM | 9.9 | 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 | |
| Alcohol | INACTIVE INGREDIENT | 3K9958V90M | 1 | |
| Butylene Glycol | INACTIVE INGREDIENT | 3XUS85K0RA | 1 | |
| Dipropylene Glycol | INACTIVE INGREDIENT | E107L85C40 | 1 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| Hydrogenated Soybean Lecithin | INACTIVE INGREDIENT | H1109Z9J4N | 1 | |
| Isododecane | INACTIVE INGREDIENT | A8289P68Y2 | 1 | |
| Isohexadecane | INACTIVE INGREDIENT | 918X1OUF1E | 1 | |
| Lysine | INACTIVE INGREDIENT | K3Z4F929H6 | 1 | |
| Magnesium Chloride | INACTIVE INGREDIENT | 02F3473H9O | 1 | |
| Mica | INACTIVE INGREDIENT | V8A1AW0880 | 1 | |
| Pentylene Glycol | INACTIVE INGREDIENT | 50C1307PZG | 1 | |
| Potassium Chloride | INACTIVE INGREDIENT | 660YQ98I10 | 1 | |
| Sodium Chloride | INACTIVE INGREDIENT | 451W47IQ8X | 1 | |
| Sodium Citrate | INACTIVE INGREDIENT | 1Q73Q2JULR | 1 | |
| Triethylhexanoin | INACTIVE INGREDIENT | 7K3W1BIU6K | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 66184-465 | 66184-465-01, 66184-465-02 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Titanium Dioxide | 15FIX9V2JP | ACTIB |
| Octinoxate | 4Y5P7MUD51 | ACTIB |
| Water | 059QF0KO0R | IACT |
| Isohexadecane | 918X1OUF1E | IACT |
| Butylene Glycol | 3XUS85K0RA | IACT |
| Hydrogenated Soybean Lecithin | H1109Z9J4N | IACT |
| Alcohol | 3K9958V90M | IACT |
| Triethylhexanoin | 7K3W1BIU6K | IACT |
| Pentylene Glycol | 50C1307PZG | IACT |
| Glycerin | PDC6A3C0OX | IACT |
| Lysine | K3Z4F929H6 | IACT |
| Isododecane | A8289P68Y2 | IACT |
| Dipropylene Glycol | E107L85C40 | IACT |
| Magnesium Chloride | 02F3473H9O | IACT |
| Sodium Chloride | 451W47IQ8X | IACT |
| Potassium Chloride | 660YQ98I10 | IACT |
| Sodium Citrate | 1Q73Q2JULR | IACT |
| Mica | V8A1AW0880 | IACT |
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 |
|---|---|---|---|---|---|---|
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 24 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SHAMPOO / TOPICAL | 5 %w/w | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / PERIDURAL | 8.07 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SPRAY, METERED / NASAL | 13 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / RECTAL | 440 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRATHECAL | 9 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION, LIPOSOMAL / EPIDURAL | 11 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL, METERED / NASAL | 70 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL / DENTAL | 1.8 %w/w | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / TOPICAL | 210 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / INTRACAUDAL | 210 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / SUBCUTANEOUS | 6.1 %v/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, COATED / ORAL | 14.21 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | TABLET, CHEWABLE / ORAL | 20 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | LIQUID / ORAL | 3563 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SPRAY / TOPICAL | 3633 mg | ||
| Potassium Chloride | POTASSIUM CHLORIDE | 660YQ98I10 | INJECTION, SOLUTION / INTRAVENOUS | 330 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / AURICULAR (OTIC) | 25 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | CAPSULE / ORAL | 6 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRA-ARTICULAR | 26 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | TABLET, DELAYED RELEASE / ORAL | 97 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVENOUS | 99 mg | ||
| Potassium Chloride | POTASSIUM CHLORIDE | 660YQ98I10 | INJECTION / INTRAVENOUS | 1 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / INTRAVENOUS | 90 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / IONTOPHORESIS | 0.6 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | DROPS / NASAL | 10 mg/1ml | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | ELIXIR / ORAL | 1 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION, CONCENTRATE / ORAL | 150.68 mg/1ml | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR | 45 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRAMUSCULAR | 1486 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION/ DROPS / OPHTHALMIC | 3 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL / TOPICAL | 561 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | CAPSULE / ORAL | 882 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | GEL / VAGINAL | 10 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION / SUBCUTANEOUS | 149 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / SUBCUTANEOUS | 90 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SPRAY / NASAL | 20 mg | ||
| Potassium Chloride | POTASSIUM CHLORIDE | 660YQ98I10 | CAPSULE / ORAL | 62 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SPRAY / NASAL | 30 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS | 0.86 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / TOPICAL | 2445 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | GRANULE, FOR SUSPENSION / ORAL | 162 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | LIQUID / INTRAMUSCULAR | 400 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | DROPS / NASAL | NA | ||
| Alcohol | ALCOHOL | 3K9958V90M | DROPS / ORAL | 210 mg/1ml | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / RETROBULBAR | 648 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / PERINEURAL | 648 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | LIQUID / INTRAVENOUS | 400 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SUSPENSION / RECTAL | 0.35 %v/v | ||
| Potassium Chloride | POTASSIUM CHLORIDE | 660YQ98I10 | INJECTION / INFILTRATION | 0.3 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | 0.68 %w/v | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SOLUTION / INTRAPLEURAL | 226 mg | ||
| Magnesium Chloride | MAGNESIUM CHLORIDE | 02F3473H9O | SOLUTION/ DROPS / OPHTHALMIC | 0.03 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL, METERED / TRANSDERMAL | 3675 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL / TOPICAL | 9971 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL, METERED / RESPIRATORY (INHALATION) | 26664 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SYRUP / ORAL | 40 mg | ||
| Potassium Chloride | POTASSIUM CHLORIDE | 660YQ98I10 | SOAP / TOPICAL | NA | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | GEL / OPHTHALMIC | 0.88 %w/w | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | TABLET, EXTENDED RELEASE / ORAL | 335.1 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 |
|---|---|---|---|---|---|---|
| af503a65-f996-485c-94f8-1d72ad56ec7e | ae8fd4a3-78ba-4591-a9e2-d25e3cbf0b75 | 2012-01-23 | Warnings | af503a65-f996-485c-94f8-1d72ad56ec7e ae8fd4a3-78ba-4591-a9e2-d25e3cbf0b75 |
Adverse event summaries are temporarily unavailable. Other product information remains available.