OTC - ACTIVE INGREDIENT SECTION
Active Ingredient:
Titanium Dioxide: 8.5%
Octinoxate: 7.5%
Octocrylene: 4.0%
Octisalate: 2.0%
Active Ingredient:
Titanium Dioxide: 8.5%
Octinoxate: 7.5%
Octocrylene: 4.0%
Octisalate: 2.0%
Purpose:
Sunscreen
Uses:
Helps prevent sunburn
Warning:
For external use only
Skin Cancer/ Skin Aging Alert: Spending time in the sun increases your risk of skin cancer or early skin aging. This product has been shown to only protect you from sunburn, not skin cancer or sking aging.
When using this product:
Keep out of eyes. Rinse with water to remove.
Stop Use and Ask a Doctor if:
Rash occurs
Keep Out of Reach of Children
Directions:
Apply generously 15 min before sun exposure.
Children under six months of age: ask a doctor.
Reapply at least every two hours.
Use a water resistant sunscreen if swimming or sweating
Sun Protection Measures:
Spending time in sun increases your risk of skin cancer or early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF value of 15 or higher and other sun protection measures including
Other Information:
Protect this product in the container from excessive heat and direct sun
Store at room temperature 15-30 C (59-86F)
Inactive Ingredient:
Water, Cyclopentasiloxane, Dimethicone, Isododecane, Phenyl Trimethicone, Silica, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Talc, Cetyl PEG/PEG-10/1 Dimethicone, Sodium Chloride, Acrylates/Dimethicone Copolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethicone/PEG-10/15 Crosspolymer, Disteardimonium Hectorite, Propylene Carbonate, Disodium EDTA Alumina, Pentaerythrityl Tetraisostearate, Paraffinum Liguidum (mineral Oil), Palmitoyl Peptide-1, Punica Granatum Seed Oil, Vitis Vinifera (Grape) Seed Oil, Retinyl Palmitate (VA), Tocopheryl Acetate (VE), Bisabolol, Ascorbyl Palmitate (VC), Lycium Chinese Fruit Extract, Butylene Glycol, Triethoxycaprylylsilane, Phenoxyethanol, Caprylyl Glycol
May contain:
Iron Oxides (CI 77491, CI 77492, CI 77499)
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 76354-621-01 | 2020-02-26 | C162847 | 48780-1 | 9d75b9d0-d9b1-f424-e053-dadaa90a57ce | Drug Fact |
| 76354-621-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-d9b1-f424-e053-dadaa90a57ce | Drug Fact |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 76354-621 | 76354-621-01 |
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 |
|---|---|---|---|---|---|---|
| c9f283ce-6daa-4872-a26b-66543efda712 | 906ee554-11bf-491d-9abe-3193e4afb3da | 2017-05-27 | Warnings | c9f283ce-6daa-4872-a26b-66543efda712 906ee554-11bf-491d-9abe-3193e4afb3da |
Adverse event summaries are temporarily unavailable. Other product information remains available.