OTC - ACTIVE INGREDIENT SECTION
Active ingredients--------------purpose
HOMOSALATE 3%------------Sunscreen SPF15
OCTINOXATE 6%
Active ingredients--------------purpose
HOMOSALATE 3%------------Sunscreen SPF15
OCTINOXATE 6%
Uses:
help prevent sunburn
Warnings:
Skin Cancer / Skin Aging Alert: Spending time in the 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 external use only. Kepp out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash or irritation develops and lasts. Keep out of reach of children. If swallowed: seek medical help or contact a poison control center right away.
Directions:
Apply liberally 15mintues before sun exposure and reapply as needed.
Children under 6 months: ask a doctor before use.
Inactive Ingredients:
PROPYLENE GLYCOL, CYCLOMETHICONE, PEG-40 CASTOR OIL, SODIUM HYDROXIDE, CARBOMER 1342, METHYLPARABEN, IODOPROPYNYL BUTYLCARBAMATE, DISODIUM EDTA-COPPER, WATER
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 47993-215-01 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-154e-a910-e053-dadaa90a0b85 | Active Ingredients |
| 47993-215-02 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-154e-a910-e053-dadaa90a0b85 | Active Ingredients |
| 47993-215-03 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-154e-a910-e053-dadaa90a0b85 | Active Ingredients |
| 47993-215-05 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-154e-a910-e053-dadaa90a0b85 | Active Ingredients |
| 47993-215-06 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-154e-a910-e053-dadaa90a0b85 | Active Ingredients |
| 47993-215-08 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-154e-a910-e053-dadaa90a0b85 | Active Ingredients |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 47993-215-01 | SUN BLOCK SPRARY | 10 g in 1 BOTTLE | SPRAY | 10 | 6 | |
| 47993-215-02 | SUN BLOCK SPRARY | 15 g in 1 BOTTLE | SPRAY | 15 | 6 | |
| 47993-215-03 | SUN BLOCK SPRARY | 30 g in 1 BOTTLE | SPRAY | 30 | 6 | |
| 47993-215-05 | SUN BLOCK SPRARY | 60 g in 1 BOTTLE | SPRAY | 60 | 6 | |
| 47993-215-06 | SUN BLOCK SPRARY | 80 g in 1 BOTTLE | SPRAY | 80 | 6 | |
| 47993-215-08 | SUN BLOCK SPRARY | 100 g in 1 BOTTLE | SPRAY | 100 | 6 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Homosalate | ACTIVE INGREDIENT | V06SV4M95S | 1 | |
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| HOMOSALATE | ACTIVE MOIETY | V06SV4M95S | 1 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| CARBOMER 1342 | INACTIVE INGREDIENT | 809Y72KV36 | 1 | |
| CYCLOMETHICONE | INACTIVE INGREDIENT | NMQ347994Z | 1 | |
| DISODIUM EDTA-COPPER | INACTIVE INGREDIENT | 6V475AX06U | 1 | |
| IODOPROPYNYL BUTYLCARBAMATE | INACTIVE INGREDIENT | 603P14DHEB | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| PEG-40 CASTOR OIL | INACTIVE INGREDIENT | 4ERD2076EF | 1 | |
| Propylene Glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 47993-215 | 47993-215-01, 47993-215-02, 47993-215-03, 47993-215-05, 47993-215-06, 47993-215-08 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CYCLOMETHICONE | NMQ347994Z | IACT |
| PEG-40 CASTOR OIL | 4ERD2076EF | IACT |
| DISODIUM EDTA-COPPER | 6V475AX06U | IACT |
| CARBOMER 1342 | 809Y72KV36 | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| IODOPROPYNYL BUTYLCARBAMATE | 603P14DHEB | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| WATER | 059QF0KO0R | IACT |
| HOMOSALATE | V06SV4M95S | ACTIB |
| OCTINOXATE | 4Y5P7MUD51 | ACTIB |
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 HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRA-ARTICULAR | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRA-ARTERIAL | 176 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | CAPSULE, COATED PELLETS / ORAL | 0.01 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / AURICULAR (OTIC) | 0.8 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | MOUTHWASH / BUCCAL | 2 mg/1ml | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | FILM, EXTENDED RELEASE / TRANSDERMAL | 0.85 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / NASAL | 20 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, DELAYED RELEASE / ORAL | 36 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM, SOLUBLE / BUCCAL | 5 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / RECTAL | 27 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / INTRAVENOUS | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS | ADJ PH | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SYSTEM / TOPICAL | 42 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION, CONCENTRATE / ORAL | 1 mg/1ml | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | LOTION / TOPICAL | 3392 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / OPHTHALMIC | 0.6 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | GEL / TRANSDERMAL | 472 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / ORAL | 1 mg/1ml | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / TOPICAL | 8 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | FILM, SOLUBLE / BUCCAL | 3 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / RECTAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | CAPSULE, LIQUID FILLED / ORAL | 1.5 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR | ADJ PH | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAVENOUS | 4000 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY / NASAL | 5 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / SUBCUTANEOUS | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRACAUDAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / IRRIGATION | ADJ PH | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SYSTEM / TOPICAL | 4200 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / RETROBULBAR | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 136.55 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | TABLET, FILM COATED / ORAL | 8 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 27 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SPRAY, METERED / NASAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / INTRATHECAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRABURSAL | ADJ PH | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / DENTAL | NA | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRAVESICAL | ADJ PH | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / SUBCUTANEOUS | 1.4 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / EPIDURAL | ADJ PH | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET / ORAL | 64 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 63.4 %w/v | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / RECTAL | 1214 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRASYNOVIAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / INTRADISCAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | ENEMA / RECTAL | 0.44 %v/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRALESIONAL | 0.15 %w/v | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CLOTH / TOPICAL | 0.03 mg/mg | ||
| CARBOMER 1342 | CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) | 809Y72KV36 | FILM, EXTENDED RELEASE / TRANSDERMAL | 38.9 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / SUBCUTANEOUS | 1 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | DROPS / OPHTHALMIC | NA | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INFILTRATION | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / PERIDURAL | ADJ PH | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SYRUP / ORAL | 5700 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / SOFT TISSUE | 0.15 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | CAPSULE, DELAYED RELEASE / ORAL | 0.25 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET / ORAL | 1.8 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / EPIDURAL | 30 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION, EXTENDED RELEASE / ORAL | 1000 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUPPOSITORY / VAGINAL | NA |
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 |
|---|---|---|---|---|---|---|
| 9579e8e7-6ab1-57ba-e053-2a95a90afd34 | 9b67cc89-2696-4759-af1e-5bd21f83f98b | 2019-10-22 | Warnings | 9579e8e7-6ab1-57ba-e053-2a95a90afd34 9b67cc89-2696-4759-af1e-5bd21f83f98b |
Adverse event summaries are temporarily unavailable. Other product information remains available.