OTC - PURPOSE SECTION
USES: HELPS PREVENT SUNBURNS
USES: HELPS PREVENT SUNBURNS
RECOMMENDATION: APPLY GENEROUSLY TO FACE BEFORE EXPOSURE TO SUN, AVOIDING CONTACT WITH EYES. REAPPLY TO EXPOSED AREAS AS NEEDED THROUGHOUT THE DAY.
CHILDREN UNDER 6 MONTHS OF AGE: CONSULT A DOCTOR BEFORE USE.
WARNING: FOR EXTERNAL USE ONLY, IF SWALLOWED, SEEK MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. IF CONTACT WITH EYES OCCURS, RINSE THOROUGHLY WITH WATER. DISCONTINUE USE AND CONSULT A DOCTOR IF PERSISTENT SIGNS OF IRRITATION OR RASH APPEAR.
KEEP OUT OF REACH OF CHILDREN.
ACTIVE INGREDIENTS:
TITANIUM DIOXIDE 9.4%
ZINC OXIDE 3.9%
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| TITANIUM DIOXIDE | ACTIVE INGREDIENT | 15FIX9V2JP | 2 | |
| ZINC OXIDE | ACTIVE INGREDIENT | SOI2LOH54Z | 2 | |
| TITANIUM DIOXIDE | ACTIVE MOIETY | 15FIX9V2JP | 2 | |
| ZINC OXIDE | ACTIVE MOIETY | SOI2LOH54Z | 2 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | 2 | |
| ALPHA-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 2 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | 2 | |
| ARABICA COFFEE BEAN | INACTIVE INGREDIENT | 3SW678MX72 | 2 | |
| ARCTIUM LAPPA ROOT | INACTIVE INGREDIENT | 597E9BI3Z3 | 2 | |
| AVOCADO OIL | INACTIVE INGREDIENT | 6VNO72PFC1 | 2 | |
| BUTYLPARABEN | INACTIVE INGREDIENT | 3QPI1U3FV8 | 2 | |
| CERAMIDE 3 | INACTIVE INGREDIENT | 4370DF050B | 2 | |
| COMFREY ROOT | INACTIVE INGREDIENT | M9VVZ08EKQ | 2 | |
| CYCLOMETHICONE 5 | INACTIVE INGREDIENT | 0THT5PCI0R | 2 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 2 | |
| DIMETHICONOL (41 MPA.S) | INACTIVE INGREDIENT | 343C7U75XW | 2 | |
| EDETATE TRISODIUM | INACTIVE INGREDIENT | 420IP921MB | 2 | |
| ETHYLPARABEN | INACTIVE INGREDIENT | 14255EXE39 | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 2 | |
| GLYCYRRHIZINATE DIPOTASSIUM | INACTIVE INGREDIENT | CA2Y0FE3FX | 2 | |
| HORSE CHESTNUT | INACTIVE INGREDIENT | 3C18L6RJAZ | 2 | |
| HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) | INACTIVE INGREDIENT | J2S07SB0YL | 2 | |
| LAVANDULA ANGUSTIFOLIA FLOWERING TOP | INACTIVE INGREDIENT | 9YT4B71U8P | 2 | |
| LEVOMENOL | INACTIVE INGREDIENT | 24WE03BX2T | 2 | |
| MAGNESIUM SULFATE | INACTIVE INGREDIENT | DE08037SAB | 2 | |
| MATRICARIA RECUTITA | INACTIVE INGREDIENT | G0R4UBI2ZZ | 2 | |
| MENTHA PULEGIUM | INACTIVE INGREDIENT | 5Q6Y7K4846 | 2 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 2 | |
| OAT | INACTIVE INGREDIENT | Z6J799EAJK | 2 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 2 | |
| PLANTAGO OVATA SEED | INACTIVE INGREDIENT | UD50RBY30F | 2 | |
| POLYSORBATE 20 | INACTIVE INGREDIENT | 7T1F30V5YH | 2 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 2 | |
| ROSEMARY | INACTIVE INGREDIENT | IJ67X351P9 | 2 | |
| SUNFLOWER OIL | INACTIVE INGREDIENT | 3W1JG795YI | 2 | |
| TETRAHEXYLDECYL ASCORBATE | INACTIVE INGREDIENT | 9LBV3F07AZ | 2 | |
| TOCOPHEROL | INACTIVE INGREDIENT | R0ZB2556P8 | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 62191-021 | 62191-021-05 |
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 |
|---|---|---|---|---|---|---|
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | POWDER, FOR SOLUTION / ORAL | 126 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET / ORAL | 8 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / IONTOPHORESIS | 0.1 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SYSTEM / TOPICAL | 21 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CREAM / VAGINAL | 3 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | GEL / TOPICAL | 24 mg | ||
| CYCLOMETHICONE 5 | CYCLOMETHICONE 5 | 0THT5PCI0R | AEROSOL / TOPICAL | 2.5 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / PARENTERAL | 2 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | OINTMENT / OPHTHALMIC | 0.05 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CREAM, AUGMENTED / TOPICAL | 2 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CAPSULE / ORAL | 7 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | TABLET, EXTENDED RELEASE / ORAL | 4.2 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, COATED PELLETS / ORAL | 2 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | TABLET, COATED / ORAL | 0.8 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | EMULSION / TOPICAL | 2 %w/w | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | GEL / TOPICAL | 5 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRALESIONAL | 0.15 %w/v | ||
| BUTYLPARABEN | BUTYLPARABEN | 3QPI1U3FV8 | SOLUTION / ORAL | 6 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / RECTAL | 0.02 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | JELLY / TOPICAL | 420 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | DROPS / AURICULAR (OTIC) | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | AEROSOL, FOAM / VAGINAL | 0.1 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SHAMPOO, SUSPENSION / TOPICAL | 0.15 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / RECTAL | 0.13 %w/v | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | SHAMPOO / TOPICAL | 8 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 15 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | TABLET / ORAL | 0.2 mg | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | TABLET / ORAL | 0.08 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | POWDER, FOR SOLUTION / ORAL | 13 mg | ||
| MAGNESIUM SULFATE | MAGNESIUM SULFATE | DE08037SAB | TABLET / ORAL | 2.9 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SPRAY / NASAL | 0.2 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | SOLUTION / TOPICAL | 15 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CONCENTRATE / ORAL | 12 mg | ||
| MAGNESIUM SULFATE | MAGNESIUM SULFATE | DE08037SAB | TABLET, EXTENDED RELEASE / ORAL | 4 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | OINTMENT / OPHTHALMIC | 0.01 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET, CHEWABLE / ORAL | 1.28 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRADERMAL | 1 mg | ||
| ALUMINUM OXIDE | ALUMINUM OXIDE | LMI26O6933 | SPONGE / TOPICAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | GRANULE, FOR SUSPENSION / ORAL | 80 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION/ DROPS / OPHTHALMIC | 0.01 %w/w | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | CAPSULE, COATED / ORAL | 0.25 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / RECTAL | 271 mg | ||
| CYCLOMETHICONE 5 | CYCLOMETHICONE 5 | 0THT5PCI0R | AEROSOL, FOAM / TOPICAL | 144 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / INTRAMUSCULAR | 0.13 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / NASAL | 250 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | SUSPENSION / ORAL | 80 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | SOAP / TOPICAL | 0.02 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | POWDER, FOR SUSPENSION / ORAL | 75 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SOLUTION / INTRAMUSCULAR | 5 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | ENEMA / RECTAL | 0.18 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERINEURAL | 80 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 60 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | CREAM, AUGMENTED / TOPICAL | 10 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / TOPICAL | 216 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | JELLY / NASAL | 250 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / INTRAMUSCULAR | 0.02 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | PASTE, DENTIFRICE / DENTAL | 0.05 %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 |
|---|---|---|---|---|---|---|
| 6b26ee28-a4aa-44bb-9227-f272879c5652 | 1ca30ae5-9998-45c3-a354-a9f3a554c128 | 2019-12-18 | Warnings | 6b26ee28-a4aa-44bb-9227-f272879c5652 1ca30ae5-9998-45c3-a354-a9f3a554c128 |
Adverse event summaries are temporarily unavailable. Other product information remains available.