SUNMITT BROAD SPECTRUM SPF-50 SUNSCREEN
- Manufacturer
- Tactopack LLC
- Effective date
- 2021-05-14
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:44:49
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SunMitt Pre-Filled Sunscreen Applicator
SunMitt
Pre-Filled Sunscreen Mitt
Pump & Apply
Hands Stay Clean
Quick and Even application with ZeroMess
100+ Dispenses
Kid friendly with no fumes
SPF50 Broad Spectrum UVA/UVB
Oxybenzone and PABA Free
Reef Safe
TSA Compliant
Unscented/Dry Finish/Water Resistant (80 Minutes)
Active Ingredients
Avobenzone 2.4%, Homosalate 12%, Octisalate 4%, Octocrylene 4.8%
Purpose
Sunscreen
Uses
Helps prevent sunburn.
If used as directed with other sun protection measures
(see Directions), decreases the risk of skin 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 product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
Apply liberally 15 minutes before sun exposure.
Reapply:
- After 80 minutes of swimming or sweating
- Immediately after towel drying
- at least every 90 minutes
Sun Protection Measures: Spending time in the sun increases your risk of skin cancer
& early skin aging. To decrease this risk, regularly use a sunscreen with a broad
spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses
Children under 6 months. Ask a doctor.
Other Information
Protect this product from excessive heat and direct sun.
May stain or damage some fabrics or surfaces.
Inactive Ingredients
Benzoic Acid, Cetyl PEG/PPG-10/1 Dimethicone, Disodium EDTA,
Ethylhexylglycerin, Glycereth-2 Cocoate, Octyldodecyl Stearyl Citrate Crosspolymer,
Phenoxyethanol, Propylene Glycol, Sodium Chloride, Water
Questions?
(914) 697-8344, info@sunmitt.com
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 78005-000-00 | 2024-03-27 | C162847 | 48780-1 | f386c649-9b16-0266-e053-dadaa90a7c1a | SUNMITT BROAD SPECTRUM SPF-50 SUNSCREEN |
| 78005-000-00 | 2023-01-30 | C162847 | 48780-1 | f386c649-9b16-0266-e053-dadaa90a7c1a | SUNMITT BROAD SPECTRUM SPF-50 SUNSCREEN |
Products#
Every source-derived product name is available through these pages.
- SUNMITT BROAD SPECTRUM SPF-50 SUNSCREEN
- Avobenzone, Homosalate, Octisalate, Octocrylene
- HOMOSALATE
- OCTOCRYLENE
- AVOBENZONE
- WATER
- OCTISALATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 78005-000 | 78005-000-00 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HOMOSALATE | V06SV4M95S | ACTIB |
| OCTOCRYLENE | 5A68WGF6WM | ACTIB |
| AVOBENZONE | G63QQF2NOX | ACTIB |
| WATER | 059QF0KO0R | IACT |
| OCTISALATE | 4X49Y0596W | ACTIB |
Source Document#
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| 14ac1dcc-462c-d07f-e063-6394a90aaa23 | a5f2092e-75fb-e7cc-e053-2a95a90a9afa | 2024-03-27 | Warnings | a5f2092e-75fb-e7cc-e053-2a95a90a9afa |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

