Indications and uses
For all sunscreen drug products: “helps prevent sunburn
For all sunscreen drug products: “helps prevent sunburn
Apply generously and evenly 15 minutes before sun exposure Reapply at least every two hours Use water resistant sun protector if swimming or sweating. Sun protection measures: Overexposure to the sun is dangerous. Increases the risk of causing skin cancer and premature aging. To reduce the risk, regularly use sunscreen with broad spectrum SPF 15 or higher, combined with other sun protection measures. Limit exposur...
Protect from excessive heat and direct sunlight. Formulated with out: Parabens, silicones, mineral oils, paraffins and synthetic fragrances
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Sunscreen
AVOBENZONE 2%
OCTOCRYLENE 2%
OCTINOXATE 6%
ENSULIZOLE 2%
OCTISALATE 4.5%
TITANIUM DIOXIDE 2.4%
For all sunscreen drug products:
“helps prevent sunburn
For external use only
keep out of eyes. Rinse with water to remove.
if rash or irritation develops or lasts.
If the product is swallowed get medical help or contact a poison control center right away.
Apply generously and evenly 15 minutes before sun exposure
Reapply at least every two hours
Use water resistant sun protector if swimming or sweating.
Sun protection measures:
Overexposure to the sun is dangerous. Increases the risk of causing skin cancer and premature aging.
To reduce the risk, regularly use sunscreen with broad spectrum SPF 15 or higher, combined with other sun protection measures.
Limit exposure time especially between 10 am - 2 pm.
Wear long sleeves, hat and glasses.
Children under 6 months of age ask a doctor.
Water/Aqua, Aloe Barbadensis Leaf Water, Coffea Arabica Seed Extract, Coffea Arabica Seed Oil, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, C12-15 Alkyl Benzoate, Aluminum Starch Octenylsuccinate, Butyl Methoxydibenzoylmethane, Phenylbenzimidazole Sulfonic Acid, Octocrylene, Propylheptyl Caprylate,Titanium Dioxide, Calendula officinalis flower extract, Cetearyl Alcohol, Dicaprylyl Carbonate(and)Stearalkonium Hectorite (and) Propylene Carbonate, Polyglyceryl-2 Dipolyhydroxystearate, Sodium Stearoyl Glutamate, Tocopheryl Acetate, Panthenol,Sodium Polyacrylate, Phenoxyethanol and Caprylyl Glycol, Xanthan Gum, Polyamide – 3, Cymbopongo citratus leaf oil , Lippia Alba Leaf/Stem Oil, Citrus nobilis (mandarin orange) peel oil, CI 77891 (Titanium dioxide), CI 77491 (Iron oxide red), CI 77492 (Iron oxide yellow), CI 77499 (Iron oxide Black).
Protect from excessive heat and direct sunlight.
Formulated with out:
Parabens, silicones, mineral oils, paraffins and synthetic fragrances
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 71801-541-01 | 2022-07-29 | C162847 | 48780-1 | ab0e2407-2f1e-f274-e053-dbdaa90a6471 | 5c4230af-280e-2b73-e053-2991aa0aa4a9 |
| 71801-541-01 | 2021-03-02 | C162847 | 48780-1 | ab0e2407-2f1e-f274-e053-dbdaa90a6471 | 5c4230af-280e-2b73-e053-2991aa0aa4a9 |
| 71801-541-01 | 2020-09-27 | C162847 | 48780-1 | ab0e2407-2f1e-f274-e053-dbdaa90a6471 | 5c4230af-280e-2b73-e053-2991aa0aa4a9 |
| 71801-541-01 | 2020-09-25 | C162847 | 48780-1 | ab0e2407-2f1e-f274-e053-dbdaa90a6471 | 5c4230af-280e-2b73-e053-2991aa0aa4a9 |
| 71801-541-01 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-2f1e-f274-e053-dbdaa90a6471 | 5c4230af-280e-2b73-e053-2991aa0aa4a9 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71801-541-01 | OCTINOXATE,OCTISALATE,AVOBENZONE,OCTOCRYLENE,ENSULIZOLE,TITANIUM DIOXIDE | 30 g in 1 BOX | CREAM | 30 | 5 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 71801-541 | 71801-541-01 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| ba61353d-f750-704e-e053-2995a90abbf2 | 5c4230af-280e-2b73-e053-2991aa0aa4a9 | 2021-02-02 | Warnings | ba61353d-f750-704e-e053-2995a90abbf2 5c4230af-280e-2b73-e053-2991aa0aa4a9 |
Adverse event summaries are temporarily unavailable. Other product information remains available.