OTC - ACTIVE INGREDIENT SECTION
ZINC OXIDE 11.04%
OCTINOXATE 7.02%
TITANIUM DIOXIDE 4.03%
ZINC OXIDE 11.04%
OCTINOXATE 7.02%
TITANIUM DIOXIDE 4.03%
For external use only
Keep out of reach of children. Is swallowed, get medical help or contact a Poison Control Center right away.
Keep out of eyes. Rinse with water to remove.
Stop use if a rash or irritation develops and lasts.
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a21a21e5-f36d-4c1f-8918-def921b8f7e3 | Product name | 3 | 20250124 |
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 290f523a-f9db-9774-b5a9-e1f908ac1782 | Product name | 1 | 20150828 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53208-502-02 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-da3f-8e05-e053-dbdaa90a074a | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53208-502-01 | ISA KNOX 365 SUN | 70 mL in 1 CONTAINER | CREAM | 70 | 2 | |
| 53208-502-02 | ISA KNOX 365 SUN | 1 in 1 BOX | CREAM | 1 | 2 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 2 | |
| TITANIUM DIOXIDE | ACTIVE INGREDIENT | 15FIX9V2JP | 2 | |
| ZINC OXIDE | ACTIVE INGREDIENT | SOI2LOH54Z | 2 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 2 | |
| TITANIUM DIOXIDE | ACTIVE MOIETY | 15FIX9V2JP | 2 | |
| ZINC OXIDE | ACTIVE MOIETY | SOI2LOH54Z | 2 | |
| ACETATE ION | INACTIVE INGREDIENT | 569DQM74SC | 2 | |
| BUTYLENE GLYCOL | INACTIVE INGREDIENT | 3XUS85K0RA | 2 | |
| CETYL ETHYLHEXANOATE | INACTIVE INGREDIENT | 134647WMX4 | 2 | |
| CHAMAEMELUM NOBILE FLOWER | INACTIVE INGREDIENT | O2T154T6OG | 2 | |
| CYCLOMETHICONE 5 | INACTIVE INGREDIENT | 0THT5PCI0R | 2 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 2 | |
| DIPROPYLENE GLYCOL | INACTIVE INGREDIENT | E107L85C40 | 2 | |
| DISTEARYLDIMONIUM CHLORIDE | INACTIVE INGREDIENT | OM9573ZX3X | 2 | |
| ETHYLPARABEN | INACTIVE INGREDIENT | 14255EXE39 | 2 | |
| FRUIT | INACTIVE INGREDIENT | C2AIY4ERZC | 2 | |
| MAGNESIUM SULFATE, UNSPECIFIED | INACTIVE INGREDIENT | DE08037SAB | 2 | |
| MARITIME PINE | INACTIVE INGREDIENT | 50JZ5Z98QY | 2 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 2 | |
| PANTHENOL | INACTIVE INGREDIENT | WV9CM0O67Z | 2 | |
| SACCHARIDE ISOMERATE | INACTIVE INGREDIENT | W8K377W98I | 2 | |
| SORBITAN SESQUIOLEATE | INACTIVE INGREDIENT | 0W8RRI5W5A | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 | |
| ZINC OXIDE | INACTIVE INGREDIENT | SOI2LOH54Z | 2 | |
| ZINC STEARATE | INACTIVE INGREDIENT | H92E6QA4FV | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 53208-502 | 53208-502-01, 53208-502-02 |
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 |
|---|---|---|---|---|---|---|
| ZINC STEARATE | ZINC STEARATE | H92E6QA4FV | TABLET / ORAL | 72 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | ELIXIR / ORAL | 800 mg | ||
| ZINC OXIDE | ZINC OXIDE | SOI2LOH54Z | SUPPOSITORY / RECTAL | 375 mg | ||
| ZINC STEARATE | ZINC STEARATE | H92E6QA4FV | TABLET / SUBLINGUAL | 2.5 mg | ||
| DIPROPYLENE GLYCOL | DIPROPYLENE GLYCOL | E107L85C40 | SYSTEM / TRANSDERMAL | 6 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / EPIDURAL | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / SUBCUTANEOUS | 0.16 %w/v | ||
| ETHYLPARABEN | ETHYLPARABEN | 14255EXE39 | SOLUTION / ORAL | 14 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | OINTMENT / OPHTHALMIC | 0.05 %w/w | ||
| ZINC STEARATE | ZINC STEARATE | H92E6QA4FV | POWDER / TOPICAL | 0.1 mg/mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / ORAL | 346 mg | ||
| MAGNESIUM SULFATE, UNSPECIFIED | MAGNESIUM SULFATE | DE08037SAB | TABLET, EXTENDED RELEASE / ORAL | 4 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / ORAL | 1 mg/1ml | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / RESPIRATORY (INHALATION) | 0.03 %w/w | ||
| MAGNESIUM SULFATE, UNSPECIFIED | MAGNESIUM SULFATE | DE08037SAB | TABLET, COATED / ORAL | NA | ||
| ZINC STEARATE | ZINC STEARATE | H92E6QA4FV | TABLET, FILM COATED / ORAL | 15.2 mg | ||
| CYCLOMETHICONE 5 | CYCLOMETHICONE 5 | 0THT5PCI0R | AEROSOL / TOPICAL | 2.5 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | GEL / VAGINAL | 8 mg | ||
| ZINC STEARATE | ZINC STEARATE | H92E6QA4FV | TABLET / BUCCAL | 2.5 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION/ DROPS / OPHTHALMIC | 0.05 %w/w | ||
| MAGNESIUM SULFATE, UNSPECIFIED | MAGNESIUM SULFATE | DE08037SAB | CAPSULE / ORAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 15 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRAMUSCULAR | 95 mg | ||
| SORBITAN SESQUIOLEATE | SORBITAN SESQUIOLEATE | 0W8RRI5W5A | OINTMENT / TOPICAL | 75 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SHAMPOO, SUSPENSION / TOPICAL | 0.15 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | EMULSION / TOPICAL | 0.2 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET, CHEWABLE / ORAL | 1.28 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / NASAL | 250 mg | ||
| ZINC OXIDE | ZINC OXIDE | SOI2LOH54Z | SOLUTION / INTRAVENOUS | 3.11 %w/v | ||
| ZINC OXIDE | ZINC OXIDE | SOI2LOH54Z | SOLUTION / RESPIRATORY (INHALATION) | 3.11 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / SOFT TISSUE | 0.15 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / INTRAVENOUS | 0.13 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / INTRAMUSCULAR | 45 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | GRANULE, FOR SUSPENSION / ORAL | 80 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / IRRIGATION | 2 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CONCENTRATE / ORAL | 12 mg | ||
| ZINC STEARATE | ZINC STEARATE | H92E6QA4FV | SHAMPOO / TOPICAL | 2 %w/w | ||
| ETHYLPARABEN | ETHYLPARABEN | 14255EXE39 | POWDER, FOR SOLUTION / ORAL | 13 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | POWDER, FOR SUSPENSION / ORAL | 75 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 3.6 mg | ||
| ETHYLPARABEN | ETHYLPARABEN | 14255EXE39 | GRANULE, FOR SOLUTION / ORAL | 14 mg | ||
| CYCLOMETHICONE 5 | CYCLOMETHICONE 5 | 0THT5PCI0R | CREAM, AUGMENTED / TOPICAL | 260 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | POWDER / ORAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / INTRAVENOUS | 45 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / OPHTHALMIC | 0.05 %w/w | ||
| CYCLOMETHICONE 5 | CYCLOMETHICONE 5 | 0THT5PCI0R | AEROSOL, FOAM / TOPICAL | 144 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / SUBCUTANEOUS | 22 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INFILTRATION | 80 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / RECTAL | 1808 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / ORAL | 388 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CAPSULE, EXTENDED RELEASE / ORAL | 2 mg | ||
| DIPROPYLENE GLYCOL | DIPROPYLENE GLYCOL | E107L85C40 | FILM, EXTENDED RELEASE / TRANSDERMAL | 296 mg | ||
| ZINC STEARATE | ZINC STEARATE | H92E6QA4FV | SYRUP / ORAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | LIQUID / ORAL | 162 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / INTRAMUSCULAR | 0.13 %w/v | ||
| ZINC OXIDE | ZINC OXIDE | SOI2LOH54Z | INJECTION, SUSPENSION / SUBCUTANEOUS | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION/ DROPS / OPHTHALMIC | 0.05 %w/v | ||
| ZINC OXIDE | ZINC OXIDE | SOI2LOH54Z | INJECTION / SUBCUTANEOUS | 0.02 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / AURICULAR (OTIC) | 0.01 %w/w |
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 |
|---|---|---|---|---|---|---|
| 2bda68ca-7ba8-45b6-807f-e1d4d22f1f50 | 3b33257d-1e24-460c-ae1b-43b7ff9fc666 | 2011-03-10 | Warnings | 2bda68ca-7ba8-45b6-807f-e1d4d22f1f50 3b33257d-1e24-460c-ae1b-43b7ff9fc666 |
Adverse event summaries are temporarily unavailable. Other product information remains available.