90340 Duke Cannon Cannonbalm Spf 15

90340 Duke Cannon Cannonbalm Spf 15
SPL v3
SPL
SPL Set ID f70a0173-c8ba-da7c-e053-6294a90a67db
Route
TOPICAL
Published
Effective Date 2025-12-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (0.255 g) Avobenzone (0.34 g) Octinoxate (1.105 g) Octisalate (0.85 g)
Inactive Ingredients
Sunflower Oil Yellow Wax Coconut Oil Shea Butter Peppermint Oil Tamanu Oil Green Tea Leaf Tocopherol Calendula Officinalis Flower Stevia Rebaudiuna Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-05-07

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses • H elps prevent sunburn

Dosage and Administration

Directions

  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a 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 with a broad spectrum 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
Description

Drug Facts

Section 43683-2

Uses section: added a bullet

Directions section: moved the "children under six" bullet point before the "sun protection measures" bullet.

Section 44425-7

Other Information • p rotect the product in this container from excessive heat and direct sun

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if • rash occurs

Section 50567-7

When using this product • keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use • on damaged or broken skin

Section 51727-6

Inactive Ingredients helianthus annuus (sunflower) oil*, cera flava (beeswax)*, cocos nucifera (coconut) oil*, butyrospermum parkii (shea) butter*, mentha piperita (peppermint) oil, natural flavor, calophyllum inophyllum (tamanu) oil*, camellia sinensis (matcha tea)*, tocopherol (vitamin e), calendula officinalis extract*, stevia rebaudiana* *organic ingredient

Section 53413-1

Questions or Comments? 1-855-354-4438

Section 55105-1

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Section 55106-9

Active Ingredients

Avobenzone 2%

Octinoxate 6.5%

Octisalate 5%

Octocrylene 1.5%

Drug Facts

Drug Facts

Tube Label

Blister Card

Tube Label Text

DUKE

CANNON

SUPPLY CO.

CANNON BALM ®

OFFENSIVELY LARGE ® SUNSCREEN LIP BALM

FRESH MINT

SPF 15 BROAD SPECTRUM

SPF 15 SUNSCREEN

A PORTION OF PROCEEDS BENEFITS U.S. VETERANS

MADE IN USA WITH DOMESTIC

& GLOBALLY SOURCED MATERIALS

NET WT. 0.60 OZ (17g)

DISTRIBUTED BY

DUKE CANNON SUPPLY CO.

MINNEAPOLIS, MN 55401

1-855-354-4438

PEEL HERE FOR DRUG FACTS

Blister Carton Text

DUKE

CANNON TM

SUPPLY CO

OFFENSIVELY LARGE ®

CANNON

BALM ®

BROAD SPECTRUM SPF 15

SUNSCREEN LIP BALM

SPF 15

FRESH

MINT

4x

BIGGER

THAN COMMON

LIP BALMS

A PORTION OF PROCEEDS

BENEFITS U.S. VETERANS

NET WT 0.60 OZ (17G)

BUILT TO LAST AND THEN SOME

This industrial-sized lip protectant is 4X larger than the

candy-flavored junk they sell at gas station checkout

counters. Built to meet the needs of U.S. Military personnel,

Cannon Balm ®'s unique formulation holds up in the harshest

conditions thanks to premium ingredients like organic

beeswax and shea butter. Our stick provides broad spectrum

SPF 15 protection against UV rays and has a cooling mint

flavor that makes your lips feel factory fresh.

ORGANIC BEESWAX TO HYDRATE

ORGANIC SHEA BUTTER TO SOFTEN AND SOOTHE

SPF 15 TO DEFEND AGAINST UV RAYS

FORMULATED WITHOUT PARABENS, PHTHALATES, AND PETROLATUM.

NEVER TESTED ON ANIMALS. JUST BAD INTERNS

MADE IN THE USA WITH DOMESTIC & GLOBALLY SOURCED MATERIALS.

DIST. BY DUKE CANNON SUPPLY CO. MINNEAPOLIS, MN 55401

1-855-354-4438


Structured Label Content

Indications and Usage (34067-9)

Uses • H elps prevent sunburn

Dosage and Administration (34068-7)

Directions

  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a 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 with a broad spectrum 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
Warnings and Precautions (34071-1)

Warnings

For external use only

Section 43683-2 (43683-2)

Uses section: added a bullet

Directions section: moved the "children under six" bullet point before the "sun protection measures" bullet.

Section 44425-7 (44425-7)

Other Information • p rotect the product in this container from excessive heat and direct sun

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if • rash occurs

Section 50567-7 (50567-7)

When using this product • keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use • on damaged or broken skin

Section 51727-6 (51727-6)

Inactive Ingredients helianthus annuus (sunflower) oil*, cera flava (beeswax)*, cocos nucifera (coconut) oil*, butyrospermum parkii (shea) butter*, mentha piperita (peppermint) oil, natural flavor, calophyllum inophyllum (tamanu) oil*, camellia sinensis (matcha tea)*, tocopherol (vitamin e), calendula officinalis extract*, stevia rebaudiana* *organic ingredient

Section 53413-1 (53413-1)

Questions or Comments? 1-855-354-4438

Section 55105-1 (55105-1)

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Section 55106-9 (55106-9)

Active Ingredients

Avobenzone 2%

Octinoxate 6.5%

Octisalate 5%

Octocrylene 1.5%

Drug Facts

Drug Facts

Tube Label

Blister Card

Tube Label Text

DUKE

CANNON

SUPPLY CO.

CANNON BALM ®

OFFENSIVELY LARGE ® SUNSCREEN LIP BALM

FRESH MINT

SPF 15 BROAD SPECTRUM

SPF 15 SUNSCREEN

A PORTION OF PROCEEDS BENEFITS U.S. VETERANS

MADE IN USA WITH DOMESTIC

& GLOBALLY SOURCED MATERIALS

NET WT. 0.60 OZ (17g)

DISTRIBUTED BY

DUKE CANNON SUPPLY CO.

MINNEAPOLIS, MN 55401

1-855-354-4438

PEEL HERE FOR DRUG FACTS

Blister Carton Text

DUKE

CANNON TM

SUPPLY CO

OFFENSIVELY LARGE ®

CANNON

BALM ®

BROAD SPECTRUM SPF 15

SUNSCREEN LIP BALM

SPF 15

FRESH

MINT

4x

BIGGER

THAN COMMON

LIP BALMS

A PORTION OF PROCEEDS

BENEFITS U.S. VETERANS

NET WT 0.60 OZ (17G)

BUILT TO LAST AND THEN SOME

This industrial-sized lip protectant is 4X larger than the

candy-flavored junk they sell at gas station checkout

counters. Built to meet the needs of U.S. Military personnel,

Cannon Balm ®'s unique formulation holds up in the harshest

conditions thanks to premium ingredients like organic

beeswax and shea butter. Our stick provides broad spectrum

SPF 15 protection against UV rays and has a cooling mint

flavor that makes your lips feel factory fresh.

ORGANIC BEESWAX TO HYDRATE

ORGANIC SHEA BUTTER TO SOFTEN AND SOOTHE

SPF 15 TO DEFEND AGAINST UV RAYS

FORMULATED WITHOUT PARABENS, PHTHALATES, AND PETROLATUM.

NEVER TESTED ON ANIMALS. JUST BAD INTERNS

MADE IN THE USA WITH DOMESTIC & GLOBALLY SOURCED MATERIALS.

DIST. BY DUKE CANNON SUPPLY CO. MINNEAPOLIS, MN 55401

1-855-354-4438


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