Tactopack (as PLD) - SUNMITT BROAD SPECTRUM SPF-50 SUNSCREEN (78005-000) - DELIST

SUNMITT BROAD SPECTRUM SPF-50 SUNSCREEN by

Drug Labeling and Warnings

SUNMITT BROAD SPECTRUM SPF-50 SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Tactopack LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUNMITT BROAD SPECTRUM SPF-50 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion 
Tactopack LLC

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Tactopack (as PLD) - SUNMITT BROAD SPECTRUM SPF-50 SUNSCREEN (78005-000) - DELIST

DIRECTIONS

DIRECTIONS

USES

USES

KEEP OUT OF REACH OF CHILDREN

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

SUNMITT BROAD SPECTRUM SPF-50 SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78005-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	12 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4.8 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.4 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78005-000-00	89 mL in 1 POUCH; Type 0: Not a Combination Product	07/28/2020	12/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/15/2020	12/31/2023

Labeler - Tactopack LLC (117472239)

Revised: 3/2024

Document Id: 14ac1dcc-462c-d07f-e063-6394a90aaa23

34390-5

Set id: a5f2092e-75fb-e7cc-e053-2a95a90a9afa

Version: 3

Effective Time: 20240327