Storage and handling
Other information - protect the product in this container from excessive heat and direct sun
Other information - protect the product in this container from excessive heat and direct sun
Active ingredients
Avobenzone (Butyl Methoxydibenzoylmethane) 3.0%
Homosalate, 10.0%
Octisalate, (Ehtylhexyl Salicylate) 5.0%
Octocrylene, 2.0%
Oxybenzone (Benzophenone-3) 4.0%
Purpose
Sunscreen
Sunscreen
Sunscreen
Sunscreen
Sunscreen
Uses
-helps prevent sunburn
-if used as directed with other sun protection measures (see
Directions), decreases the risk of kin cancer and early skin aging
caused by the sun.
Warnings
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 a doctor -if rash occurs
Keep out of reach of children -If swallowed, get medical help or contact
a Poison Control Center right away.
Directions
-apply liberally 15 minutes before sun exposure
-reapply at least every two hours
-use water resistant sunscreen if swimming or sweating
-children under 6 months of age: ask a doctor
Sun Protection Measures: Spending time in the sun increases
your risk of skin cancer and early skin aging. To decrease this risk,
regularly use a sunscreen witha Broad Spectrum SPF value of 15
or higher and other sun protection measures including:
-limit time in the sun, especially from 10 a.m. - 2 p.m.
-wear long-sleeved shirts, pants, hats and sunglasses
Other information - protect the product in this container from
excessive heat and direct sun
Inactive ingredients: isohexadecane, dimethicone/bis-isobutyl
PPG-20 crosspolymer, caprylic/capric triglyceride,
fragrance/parfum, tocopheryl acetate (vitamin E), bisabolol, coffee
arabica seed extract
Questions {or comments}? 1-844-331-1224
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 42421-802-16 | 2023-06-17 | C162847 | 48780-1 | 9d75b9d0-193c-f424-e053-dadaa90a57ce | callysee facial balm |
| 42421-802-16 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-193c-f424-e053-dadaa90a57ce | callysee facial balm |
| 42421-802-16 | 2021-11-04 | C162847 | 48780-1 | 9d75b9d0-193c-f424-e053-dadaa90a57ce | callysee facial balm |
| 42421-802-16 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-193c-f424-e053-dadaa90a57ce | callysee facial balm |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 42421-802 | 42421-802-16 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ISOHEXADECANE | 918X1OUF1E | IACT |
| DIMETHICONE | 92RU3N3Y1O | IACT |
| BIS-ISOBUTYLENE PPG-20 | 5R9772B6IK | IACT |
| CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE | FJ1H6M2JG9 | IACT |
| .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | IACT |
| LEVOMENOL | 24WE03BX2T | IACT |
| ARABICA COFFEE BEAN | 3SW678MX72 | IACT |
| AVOBENZONE | G63QQF2NOX | ACTIB |
| HOMOSALATE | V06SV4M95S | ACTIB |
| OCTISALATE | 4X49Y0596W | ACTIB |
| OCTOCRYLENE | 5A68WGF6WM | ACTIB |
| OXYBENZONE | 95OOS7VE0Y | ACTIB |
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 |
|---|---|---|---|---|---|---|
| fe52db42-2bf5-6877-e053-6294a90a8eb6 | ed9bab86-2ad2-419e-8d38-9ccdea0b00bb | 2023-06-17 | Warnings | ed9bab86-2ad2-419e-8d38-9ccdea0b00bb |
Adverse event summaries are temporarily unavailable. Other product information remains available.