Dosage and administration
Apply to skin prior to sun exposure and reapply as needed.
Apply to skin prior to sun exposure and reapply as needed.
Octinoxate 7.5%
Octisalate 4.0%
Zinc Oxide 7.8%
For external use only. Keep out of reach of children. If swallowed get medical help or contact a poison control center right away.
Not for resale.
Apply to skin prior to sun exposure and reapply as needed.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 66078-440-03 | 2019-11-27 | C162847 | 48780-1 | 9855d018-e642-cd31-e053-dbdaa90ab51a | f08c3d52-8efd-4f70-9318-58b93ae7c8c9 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66078-440-03 | Sun Total Protector 30 broad spectrum SPF 30 daily protection | 10.8 g in 1 TUBE | CREAM | 10.8 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| OCTISALATE | ACTIVE INGREDIENT | 4X49Y0596W | 1 | |
| ZINC OXIDE | ACTIVE INGREDIENT | SOI2LOH54Z | 1 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| OCTISALATE | ACTIVE MOIETY | 4X49Y0596W | 1 | |
| ZINC OXIDE | ACTIVE MOIETY | SOI2LOH54Z | 1 | |
| ALLANTOIN | INACTIVE INGREDIENT | 344S277G0Z | 1 | |
| C12-15 ALKYL BENZOATE | INACTIVE INGREDIENT | A9EJ3J61HQ | 1 | |
| CETYL HYDROXYETHYLCELLULOSE (350000 MW) | INACTIVE INGREDIENT | T7SWE4S2TT | 1 | |
| DIAZOLIDINYL UREA | INACTIVE INGREDIENT | H5RIZ3MPW4 | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | 1 | |
| GLYCERYL STEARATE SE | INACTIVE INGREDIENT | FCZ5MH785I | 1 | |
| IODOPROPYNYL BUTYLCARBAMATE | INACTIVE INGREDIENT | 603P14DHEB | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| PEG-100 STEARATE | INACTIVE INGREDIENT | YD01N1999R | 1 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| STEARETH-100 | INACTIVE INGREDIENT | 4OH5W9UM87 | 1 | |
| STEARETH-2 | INACTIVE INGREDIENT | V56DFE46J5 | 1 | |
| TOCOPHERYL NICOTINATE, D-.ALPHA. | INACTIVE INGREDIENT | WI1J5UCY5C | 1 | |
| TRICONTANYL POVIDONE (4 TRICONTANYL BRANCHES/REPEAT) | INACTIVE INGREDIENT | N0SS3Q238D | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 66078-440 | 66078-440-03 |
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 |
|---|---|---|---|---|---|---|
| STEARETH-100 | STEARETH-100 | 4OH5W9UM87 | CREAM / TOPICAL | 50 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | FILM / BUCCAL | 0.22 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | POWDER, FOR SUSPENSION / ORAL | 285 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | EMULSION / TOPICAL | 0.06 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INFILTRATION | 6 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, COATED / ORAL | 14.21 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET / ORAL | 56 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CREAM, AUGMENTED / TOPICAL | 2 mg | ||
| STEARETH-2 | STEARETH-2 | V56DFE46J5 | OINTMENT / TOPICAL | 714 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAMUSCULAR | 450 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SYSTEM / TOPICAL | 126 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CAPSULE, EXTENDED RELEASE / ORAL | 32.4 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | PASTE, DENTIFRICE / DENTAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 3.6 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL, FOAM / TOPICAL | 21 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / RECTAL | 1808 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, DELAYED RELEASE / ORAL | 100 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / SOFT TISSUE | 0.05 %w/v | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / OPHTHALMIC | 2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / TRANSDERMAL | 306.2 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | EMULSION / OPHTHALMIC | 0.3 %w/v | ||
| DIAZOLIDINYL UREA | DIAZOLIDINYL UREA | H5RIZ3MPW4 | CREAM / TOPICAL | 29 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SYSTEM / TOPICAL | 21 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | AEROSOL, FOAM / TOPICAL | 0.05 %w/w | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | POWDER, FOR SOLUTION / ORAL | 10 mg/5ml | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION / OPHTHALMIC | 0.06 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SUSPENSION / INTRAMUSCULAR | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / OPHTHALMIC | 0.01 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | TABLET, CHEWABLE / ORAL | 0.14 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, CHEWABLE / ORAL | 12 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | FILM, SOLUBLE / BUCCAL | 3 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / AURICULAR (OTIC) | 0.01 %w/v | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SOLUTION / OPHTHALMIC | 0.6 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | JELLY / NASAL | 250 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CAPSULE / ORAL | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRALESIONAL | 0.15 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | LOTION / TOPICAL | 22 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | AEROSOL, FOAM / TOPICAL | 0.04 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | POWDER, FOR SUSPENSION / ORAL | 75 mg | ||
| STEARETH-2 | STEARETH-2 | V56DFE46J5 | AEROSOL, FOAM / TOPICAL | 1.09 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CREAM / VAGINAL | 22 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SOLUTION / INTRAVENOUS | 5 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | LOTION / TOPICAL | 1 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERINEURAL | 80 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | OINTMENT / TOPICAL | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | GEL / VAGINAL | 8 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / AURICULAR (OTIC) | NA | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | PASTE / ORAL | 1050 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SHAMPOO / TOPICAL | 5 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SUSPENSION / SUBCUTANEOUS | 0.02 %w/v | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | AEROSOL, FOAM / TOPICAL | 3.27 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPONGE / TOPICAL | 2 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | DROPS / OPHTHALMIC | 0.05 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, EXTENDED RELEASE / ORAL | 10 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | OINTMENT / TOPICAL | NA | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SUSPENSION / INTRA-ARTICULAR | 1 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | JELLY / NASAL | 140 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CONCENTRATE / ORAL | 1800 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 |
|---|---|---|---|---|---|---|
| 73126032-358a-46f5-b86d-e69c5a355836 | f08c3d52-8efd-4f70-9318-58b93ae7c8c9 | 2013-01-28 | Warnings | 73126032-358a-46f5-b86d-e69c5a355836 f08c3d52-8efd-4f70-9318-58b93ae7c8c9 |
Adverse event summaries are temporarily unavailable. Other product information remains available.