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#

ProductSUNMITT BROAD SPECTRUM SPF-50 SUNSCREEN
Active ingredientHOMOSALATE, OCTOCRYLENE, AVOBENZONE, OCTISALATE
Label structure1 sections

Label contents#

Full prescribing information#

SunMitt Pre-Filled Sunscreen Applicator

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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)

bagbag

PouchPouch

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.4%, Homosalate 12%, Octisalate 4%, Octocrylene 4.8%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INTENDED USE OF THE DEVICE

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

WARNINGS SECTION

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

OTC - WHEN USING SECTION

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

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

May stain or damage some fabrics or surfaces.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

(914) 697-8344, info@sunmitt.com

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78005-000-002024-03-27C16284748780-1f386c649-9b16-0266-e053-dadaa90a7c1aSUNMITT BROAD SPECTRUM SPF-50 SUNSCREEN
78005-000-002023-01-30C16284748780-1f386c649-9b16-0266-e053-dadaa90a7c1aSUNMITT BROAD SPECTRUM SPF-50 SUNSCREEN

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78005-00078005-000-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
14ac1dcc-462c-d07f-e063-6394a90aaa23a5f2092e-75fb-e7cc-e053-2a95a90a9afa2024-03-27WarningsExact identifier
spl set id: a5f2092e-75fb-e7cc-e053-2a95a90a9afa

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.