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 |
|---|---|---|---|---|---|
| 66184-485-01 | 2019-11-13 | C162847 | 48780-1 | 97449f38-d40f-f6ea-e053-dbdaa90aa703 | Drug Facts |
| 66184-485-02 | 2019-11-13 | C162847 | 48780-1 | 97449f38-d40f-f6ea-e053-dbdaa90aa703 | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66184-485-01 | ck one waterfresh face makeup spf 15 800 cappucino | 9.9 g in 1 CARTRIDGE | CREAM | 9.9 | 1 | |
| 66184-485-02 | ck one waterfresh face makeup spf 15 800 cappucino | 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 |
|---|---|
| 66184-485 | 66184-485-01, 66184-485-02 |
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 |
|---|---|---|---|---|---|---|
| Glycerin | GLYCERIN | PDC6A3C0OX | PASTE / DENTAL | 20 %w/w | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / SUBMUCOSAL | 16 %w/v | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION/ DROPS / AURICULAR (OTIC) | 18 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION / INTRALESIONAL | 13 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / RECTAL | NA | ||
| Magnesium Chloride | MAGNESIUM CHLORIDE | 02F3473H9O | INJECTION, SUSPENSION / INTRAVITREAL | 0.03 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | MOUTHWASH / BUCCAL | 100 mg/1ml | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SUPPOSITORY / RECTAL | 140 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / INTRATYMPANIC | 2 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | GEL / OPHTHALMIC | 0.9 %w/v | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR | 45 mg | ||
| Potassium Chloride | POTASSIUM CHLORIDE | 660YQ98I10 | SOLUTION / INTRAOCULAR | 38 mg | ||
| Hydrogenated Soybean Lecithin | HYDROGENATED SOYBEAN LECITHIN | H1109Z9J4N | SUSPENSION / AURICULAR (OTIC) | 0.15 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SYSTEM / IONTOPHORESIS | 168.1 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 1800 mg | ||
| Potassium Chloride | POTASSIUM CHLORIDE | 660YQ98I10 | INJECTION, SOLUTION / INTRAVENOUS | 330 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUS | NA | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INFILTRATION | 648 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| Dipropylene Glycol | DIPROPYLENE GLYCOL | E107L85C40 | FILM, EXTENDED RELEASE / TRANSDERMAL | 296 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | LIQUID / RESPIRATORY (INHALATION) | 5 %w/w | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRAVITREAL | 10 %w/v | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRATUMOR | 1.2 %w/v | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / RESPIRATORY (INHALATION) | 43 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / PERINEURAL | 648 mg | ||
| Potassium Chloride | POTASSIUM CHLORIDE | 660YQ98I10 | INJECTION, SUSPENSION / INTRAVITREAL | 0.08 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / RESPIRATORY (INHALATION) | 35.75 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | AEROSOL, FOAM / TOPICAL | 21 mg | ||
| Butylene Glycol | BUTYLENE GLYCOL | 3XUS85K0RA | SYSTEM / TOPICAL | 1400 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | ELIXIR / ORAL | 5621 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | LIQUID / INTRAVENOUS | 6320 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS | 0.86 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | SPRAY / TOPICAL | 3633 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / ORAL | 1126 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | PASTE, DENTIFRICE / DENTAL | 18 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | SWAB / TOPICAL | 2250 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION / INTRAVITREAL | 6 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | TABLET, DELAYED RELEASE / ORAL | NA | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / NASAL | 25 mg/1ml | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | JELLY / VAGINAL | NA | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SOLUTION / INTRAPERITONEAL | 226 mg | ||
| Potassium Chloride | POTASSIUM CHLORIDE | 660YQ98I10 | TABLET / ORAL | 231 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | AEROSOL / TOPICAL | 3 %w/w | ||
| Potassium Chloride | POTASSIUM CHLORIDE | 660YQ98I10 | SUSPENSION / OPHTHALMIC | 0.03 %w/w | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRAVASCULAR | 0.86 %w/v | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | ELIXIR / ORAL | 1 mg | ||
| Magnesium Chloride | MAGNESIUM CHLORIDE | 02F3473H9O | SOLUTION/ DROPS / OPHTHALMIC | 0.03 %w/v | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRATHECAL | 9 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL, METERED / TRANSDERMAL | 3675 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION/ DROPS / OPHTHALMIC | 55 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION / INTRASYNOVIAL | 4 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | GEL / TOPICAL | 0.18 %w/w | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / PARENTERAL | 584 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / NASAL | 10 mg/1ml | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | DOUCHE / VAGINAL | 1 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION, CONCENTRATE / INTRAVENOUS | 4000 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 |
|---|---|---|---|---|---|---|
| dd6b5d41-08a7-4cc1-bb2f-a786568256f4 | 8480b2fb-2785-4583-97b2-4ccef2a27bba | 2012-01-23 | Warnings | dd6b5d41-08a7-4cc1-bb2f-a786568256f4 8480b2fb-2785-4583-97b2-4ccef2a27bba |
Adverse event summaries are temporarily unavailable. Other product information remains available.