Indications and uses
Helps prevent sunburn.
Helps prevent sunburn.
After cleansing apply evenly to face and neck every morning, at least 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours or after sweating. Children under 6 months of age: Ask a doctor. (Not intended for use on children)
Store at 15-30°C (59-86°F). Protect the product in this container from excessive heat and or freezing conditions.
Drug Facts
| Active Ingredient: | Purpose |
|---|---|
| Avobenzone 2.5% | Sunscreen |
| Octinoxate 4% | Sunscreen |
Stop use and ask a doctor if
Water, Carthamus Tinctorius (Safflower) Oleosomes, C12-15 Alkyl Benzoate, C13-14 Isoparrafin, Laureth 7, Polyacrylamide, Benzyl Alcohol, Fragrance, Sodium Hydroxide, Methylisothiazolinone, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, Citric Acid
Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
This product has been shown to help prevent sun burn, not skin cancer or early skin aging.
Store at 15-30°C (59-86°F). Protect the product in this container from excessive heat and or freezing conditions.
Manufactured by:
Pharmco Laboratories Inc. • Titusville, FL 32780
www.pharmcolabs.com • 1.800.635.0712 • Reorder CPL16-3
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58400-007-01 | 2020-07-10 | C162847 | 48780-1 | 9d75b9d0-5fb9-f424-e053-dadaa90a57ce | Daily Facial Moisturizer SPF 35 |
| 58400-007-02 | 2020-07-10 | C162847 | 48780-1 | 9d75b9d0-5fb9-f424-e053-dadaa90a57ce | Daily Facial Moisturizer SPF 35 |
| 58400-007-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-5fb9-f424-e053-dadaa90a57ce | Daily Facial Moisturizer SPF 35 |
| 58400-007-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-5fb9-f424-e053-dadaa90a57ce | Daily Facial Moisturizer SPF 35 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Avobenzone | ACTIVE INGREDIENT | G63QQF2NOX | 1 | |
| Octinoxate | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| Avobenzone | ACTIVE MOIETY | G63QQF2NOX | 1 | |
| Octinoxate | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| .Alpha.-Tocopherol Acetate | INACTIVE INGREDIENT | 9E8X80D2L0 | 1 | |
| Alkyl (C12-15) Benzoate | INACTIVE INGREDIENT | A9EJ3J61HQ | 1 | |
| Aloe | INACTIVE INGREDIENT | V5VD430YW9 | 1 | |
| Benzyl Alcohol | INACTIVE INGREDIENT | LKG8494WBH | 1 | |
| C13-14 Isoparaffin | INACTIVE INGREDIENT | E4F12ROE70 | 1 | |
| Carthamus Tinctorius Seed Oleosomes | INACTIVE INGREDIENT | 9S60Q72309 | 1 | |
| Laureth-7 | INACTIVE INGREDIENT | Z95S6G8201 | 1 | |
| Methylisothiazolinone | INACTIVE INGREDIENT | 229D0E1QFA | 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 |
|---|---|
| 58400-007 | 58400-007-01, 58400-007-02 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| OCTINOXATE | 4Y5P7MUD51 | ACTIB |
| AVOBENZONE | G63QQF2NOX | ACTIB |
| ALOE | V5VD430YW9 | IACT |
| BENZYL ALCOHOL | LKG8494WBH | IACT |
| CARTHAMUS TINCTORIUS SEED OLEOSOMES | 9S60Q72309 | IACT |
| ALKYL (C12-15) BENZOATE | A9EJ3J61HQ | IACT |
| C13-14 ISOPARAFFIN | E4F12ROE70 | IACT |
| LAURETH-7 | Z95S6G8201 | IACT |
| METHYLISOTHIAZOLINONE | 229D0E1QFA | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | IACT |
| WATER | 059QF0KO0R | 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 |
|---|---|---|---|---|---|---|
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | CAPSULE / ORAL | 450 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / SUBARACHNOID | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRAMUSCULAR | 78 mg | ||
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | INJECTION / INTRAMUSCULAR | 1000 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / RECTAL | NA | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION / ORAL | 400 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | LIQUID / INTRAVENOUS | ADJ PH | ||
| .Alpha.-Tocopherol Acetate | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | FILM / BUCCAL | 0.09 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / PERIDURAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRAVITREAL | ADJ PH | ||
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | SUSPENSION / TOPICAL | 1 %w/w | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / ORAL | 9120 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRAMUSCULAR | 176 mg | ||
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SUSPENSION / INTRAMUSCULAR | 40 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | GRANULE, FOR SUSPENSION / ORAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 5.4 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION / SUBCUTANEOUS | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRAVASCULAR | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / DENTAL | ADJ PH | ||
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | TABLET / ORAL | 1.06 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / URETHRAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION/ DROPS / TOPICAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SPRAY / NASAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | LIQUID / INTRAMUSCULAR | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | PASTE / DENTAL | 0.6 %w/w | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | TABLET, FILM COATED / ORAL | 8 mg | ||
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | SOLUTION / INTRAMUSCULAR | 54 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | ENEMA / RECTAL | 0.44 %v/v | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | CREAM, AUGMENTED / TOPICAL | 6 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | MOUTHWASH / BUCCAL | 2 mg/1ml | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRA-AMNIOTIC | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | POWDER / RESPIRATORY (INHALATION) | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION/ DROPS / TOPICAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRAVENOUS | 2.78 %w/v | ||
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | INJECTION / SOFT TISSUE | 23 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / INTRAVITREAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SPRAY, METERED / NASAL | ADJ PH | ||
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | SHAMPOO / TOPICAL | 1.25 %w/w | ||
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY | 8.4 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / EXTRACORPOREAL | ADJ PH | ||
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | SOLUTION / INTRAVENOUS | 242 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRAPLEURAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | OINTMENT, AUGMENTED / TOPICAL | 0.11 %w/w | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / AURICULAR (OTIC) | 0.8 %w/w | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | GEL, METERED / TRANSDERMAL | 350 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | AEROSOL, FOAM / TOPICAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | LIQUID / TOPICAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | GEL / TRANSDERMAL | 472 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRADERMAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION, EXTENDED RELEASE / INTRASYNOVIAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | POWDER, FOR SUSPENSION / ORAL | 9 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | CAPSULE, COATED PELLETS / ORAL | 0.01 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / SUBCUTANEOUS | 31.45 mg | ||
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | INJECTION / SUBCUTANEOUS | 90 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | GEL / TOPICAL | 70 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 136.55 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | DROPS / OPHTHALMIC | NA | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | POWDER, FOR SOLUTION / ORAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | ADJ PH |
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 |
|---|---|---|---|---|---|---|
| aafca3fd-4eca-48df-a312-da9b82919dff | 7bfa0e42-c909-40c3-9f7e-e0c2ca2ba16a | 2024-12-23 | Warnings | aafca3fd-4eca-48df-a312-da9b82919dff 7bfa0e42-c909-40c3-9f7e-e0c2ca2ba16a |
Adverse event summaries are temporarily unavailable. Other product information remains available.