The Men Pen Tallow Guard Spf 30 Premium Zinc Sunscreen

SPL v1

SPL

SPL Set ID 3aa3c442-26a6-0ab0-e063-6294a90a93a5

Route

TOPICAL

Published

Effective Date 2025-07-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (12 g)

Inactive Ingredients

Shea Butter Beeswax Coconut Oil Tallow

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-07-24

Description

Zinc oxide 12%

Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Apply liberally and evenly 15 minutes priorto sun exposure.Reapply after 40 minutes of swimming orsweatingimmediately after towel drying atleast every 2 hours.

Dosage and Administration

Apply evenly on the skin

Description

Zinc oxide 12%

Section 50565-1

Keep out ofreach ofchildren. if swallowed get medical help right away.

Section 50566-9

Stop use and ask doctor if rash occurs.

Rinse with water to remove.

Section 50567-7

When using this product keep out of eyes.

Section 50570-1

Do not use on damaged or broken skin.

Section 51727-6

Beeswax 51.5%

Tallow 20%

Coconut Oil 10%

Shea Butter 6%

Cedar wood Essential Oil 0.5%

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Zinc oxide 12%

Structured Label Content

Indications and Usage (34067-9)

Apply liberally and evenly 15 minutes priorto sun exposure.Reapply after 40 minutes of swimming orsweatingimmediately after towel drying atleast every 2 hours.

Dosage and Administration (34068-7)

Apply evenly on the skin

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Keep out ofreach ofchildren. if swallowed get medical help right away.

Section 50566-9 (50566-9)

Stop use and ask doctor if rash occurs.

Rinse with water to remove.

Section 50567-7 (50567-7)

When using this product keep out of eyes.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 51727-6 (51727-6)

Beeswax 51.5%

Tallow 20%

Coconut Oil 10%

Shea Butter 6%

Cedar wood Essential Oil 0.5%

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Zinc oxide 12%

Advanced Ingredient Data

[{"name": "SHEA BUTTER", "unii": "K49155WL9Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BEESWAX", "unii": "2ZA36H0S2V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCONUT OIL", "unii": "Q9L0O73W7L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALLOW", "unii": "98HPY76U4W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "12", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Apply liberally and evenly 15 minutes priorto sun exposure.Reapply after 40 minutes of swimming orsweatingimmediately after towel drying atleast every 2 hours.", "34068-7": "Apply evenly on the skin", "34071-1": "For external use only", "50565-1": "Keep out ofreach ofchildren. if swallowed get medical help right away.", "50566-9": "Stop use and ask doctor if rash occurs. Rinse with water to remove.", "50567-7": "When using this product keep out of eyes.", "50570-1": "Do not use on damaged or broken skin.", "51727-6": "Beeswax 51.5% Tallow 20% Coconut Oil 10% Shea Butter 6% Cedar wood Essential Oil 0.5%", "55105-1": "Sunscreen", "55106-9": "Zinc oxide 12%"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:36.810815 · Updated: 2026-03-14T23:09:28.158875