OTC - ACTIVE INGREDIENT SECTION
Active Ingredients:
Homosalate 10%
Octisalate 5%
Avobenzone 4%
Octocrylene 2%
Oxybenzone 4%
Active Ingredients:
Homosalate 10%
Octisalate 5%
Avobenzone 4%
Octocrylene 2%
Oxybenzone 4%
Purpose:
Homosalate 10% ..........Sunscreen
Octisalate 5% ............Sunscreen
Avobenzone 4% ..........Sunscreen
Octocrylene 2% ..........Sunscreen
Oxybenzone 4% ..........Sunscreen
If swallowed get medical help or contact a Poison Control Center
right away.
Use: Sunscreen
Directions: Apply liberally 15 minutes before sun exposure, Reapply at least every 2 hours
Warnings:
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. his product has been shown only ot prevent sunburn, not skin cancer or early skin aging
For external use only
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove
Stop use and ask doctor if rash occurs
Keep out of reach of children If swallowed get medical help or contact a Poison Control Center
right away.
Dosage and Administration:
Apply liberally 15 minutes before sun exposure
Use a water resistant Sunscreen if swimming or sweating
Reapply at least every 2 hours.
Children under 6 months: Ask a doctor
Inactive Ingredients:
Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Carbomer, Cera Alba, Hydroxyethylcellulose, Isopropyl Myristate, Methylparaben, Paraffinum Liquidum, PEG-15 Cocamine, PEG-40 stearate, Phenoxyethanol, Propylparaben, Silica, Tocopherol, Triethanolamine, Water
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| AVOBENZONE | ACTIVE INGREDIENT | G63QQF2NOX | 1 | |
| HOMOSALATE | ACTIVE INGREDIENT | V06SV4M95S | 1 | |
| OCTISALATE | ACTIVE INGREDIENT | 4X49Y0596W | 1 | |
| OCTOCRYLENE | ACTIVE INGREDIENT | 5A68WGF6WM | 1 | |
| OXYBENZONE | ACTIVE INGREDIENT | 95OOS7VE0Y | 1 | |
| AVOBENZONE | ACTIVE MOIETY | G63QQF2NOX | 1 | |
| HOMOSALATE | ACTIVE MOIETY | V06SV4M95S | 1 | |
| OCTISALATE | ACTIVE MOIETY | 4X49Y0596W | 1 | |
| OCTOCRYLENE | ACTIVE MOIETY | 5A68WGF6WM | 1 | |
| OXYBENZONE | ACTIVE MOIETY | 95OOS7VE0Y | 1 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | 1 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | 1 | |
| CARBOMER HOMOPOLYMER TYPE C | INACTIVE INGREDIENT | 4Q93RCW27E | 1 | |
| HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | INACTIVE INGREDIENT | S38J6RZN16 | 1 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | 1 | |
| PEG-15 COCAMINE | INACTIVE INGREDIENT | 8L6LB12TSJ | 1 | |
| PEG-40 STEARATE | INACTIVE INGREDIENT | ECU18C66Q7 | 1 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| TOCOPHEROL | INACTIVE INGREDIENT | R0ZB2556P8 | 1 | |
| TROLAMINE | INACTIVE INGREDIENT | 9O3K93S3TK | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| WHITE WAX | INACTIVE INGREDIENT | 7G1J5DA97F | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 55528-001 | 55528-001-50, 55528-001-30 |
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 |
|---|---|---|---|---|---|---|
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, EXTENDED RELEASE / ORAL | 450 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 0.8 mg | ||
| HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | S38J6RZN16 | SOLUTION / ORAL | 3 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SUSPENSION / SUBCUTANEOUS | 0.02 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION/ DROPS / OPHTHALMIC | 0.01 %w/w | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SOLUTION / INTRAMUSCULAR | 54 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION/ DROPS / OPHTHALMIC | 0.05 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SOLUTION / ORAL | 1.8 mg/120ml | ||
| HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | S38J6RZN16 | SUSPENSION / OPHTHALMIC | 0.25 %w/v | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | FILM / TRANSDERMAL | 58.08 mg | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | TABLET, EXTENDED RELEASE / ORAL | 14 mg | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | CAPSULE, EXTENDED RELEASE / ORAL | 71 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SOLUTION / ORAL | 360 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | GEL / VAGINAL | 8 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | PASTE / DENTAL | 95 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | NA | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | ELIXIR / ORAL | 200 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CREAM, AUGMENTED / TOPICAL | 2 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | OIL / AURICULAR (OTIC) | 36 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | GEL / VAGINAL | 2 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERIDURAL | 1 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | LIQUID / TOPICAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | PASTE, DENTIFRICE / DENTAL | 0.05 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INTRA-ARTICULAR | 0.03 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CAPSULE, EXTENDED RELEASE / ORAL | 2 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / ORAL | 300 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, FILM COATED / ORAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | ENEMA / RECTAL | 0.18 %w/v | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | TABLET / ORAL | 1.06 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | OINTMENT / TOPICAL | 0.2 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | POWDER / ORAL | NA | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | CREAM / TOPICAL | 500 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / RESPIRATORY (INHALATION) | 0.01 %w/w | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | EMULSION / TOPICAL | 0.5 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / RECTAL | 0.02 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | AEROSOL, FOAM / VAGINAL | 0.1 %w/w | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | OINTMENT / TOPICAL | 2100 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | GEL, METERED / TRANSDERMAL | 50 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CREAM / TOPICAL | 2772 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | AEROSOL, FOAM / TOPICAL | 0.16 %w/w | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | AEROSOL, METERED / RECTAL | ADJ PH | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | CREAM, AUGMENTED / TOPICAL | 10 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | GEL / TOPICAL | 6 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CAPSULE / ORAL | 1 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | CREAM, AUGMENTED / TOPICAL | 20 mg | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | CAPSULE, COATED / ORAL | 0.25 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | FILM / BUCCAL | 0.22 mg | ||
| HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | S38J6RZN16 | SOLUTION / TOPICAL | 0.21 %w/v | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | CAPSULE / ORAL | NA | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | CAPSULE, EXTENDED RELEASE / ORAL | 1.23 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | ENEMA / RECTAL | 0.02 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CREAM / VAGINAL | 51 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | POWDER / TOPICAL | 0.02 mg/mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | AEROSOL / TOPICAL | 9.3 %w/w | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | AEROSOL, FOAM / VAGINAL | 2 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SUSPENSION / SUBCUTANEOUS | 0.16 %w/v | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CAPSULE, EXTENDED RELEASE / ORAL | 120 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | CREAM, AUGMENTED / TOPICAL | 10 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 |
|---|---|---|---|---|---|---|
| bc495e74-9bbb-4b6f-b02a-2100be3266d5 | 8505aca7-f28b-4159-8d82-eac2b128e4e0 | 2019-12-18 | Warnings | 8505aca7-f28b-4159-8d82-eac2b128e4e0 |
Adverse event summaries are temporarily unavailable. Other product information remains available.