82723-004

82723-004
SPL v7
SPL
SPL Set ID 0acfdbb5-ea1d-3986-e063-6294a90afa16
Route
TOPICAL
Published
Effective Date 2023-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (21.6 g)
Inactive Ingredients
Alpha-tocopherol Acetate Medium-chain Triglycerides Cetyl Ethylhexanoate Triethoxycaprylylsilane Microcrystalline Wax Sunflower Oil Shea Butter Silicon Dioxide Squalane Coconut Oil Jojoba Oil Cocoa Butter Carnauba Wax Synthetic Wax (1200 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-01

Description

Zinc Oxide 21.6% Titanium Dioxide 23.9%

Purpose

purpose: sunscreen


Medication Information

Purpose

purpose: sunscreen

Description

Zinc Oxide 21.6% Titanium Dioxide 23.9%

Uses

Uses

Helps prevent sunburn

Higher SPF gives more sunburn protection

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

Section 50567-7

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 swallowed , get medical

help or contact a Poison Control Center right away .

Stop Use

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 swallowed , get medical

help or contact a Poison Control Center right away .

Warnings

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 swallowed , get medical

help or contact a Poison Control Center right away .

Directions

Directions

Apply liberally 15 minutes before sun exposure

Reappl.

After 80 minutes of swimming or sweating

Immediately after towel drying

At least every 2 hours-

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 agng . 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-sleeved shirts , pants , hats , and sunglasses

Do Not Use

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 swallowed , get medical

help or contact a Poison Control Center right away .

Package Label

82723-004 TATTOO MINERAL SUNSCREEN STICK

Other Information

Other information

protect this product from excessive heat and direct sun

May stain some fabrics

Active Ingredients

Zinc Oxide 21.6%

Titanium Dioxide 23.9%

Inactive Ingredients

Inactive ingredient

Caprylic / Capric Triglyceride , Cetyl Ethylhexanoate , Silica ,

TriethoxycaprylIylsilane , Microcrystalline Wax , Synthetic Wax ,

Copernicia Cerifera ( Carnauba ) Wax , Simmondsia Chinensis ( Jojoba)

Seed Oil , Theobroma Cacao ( Cocoa ) Seed Butter , Helianthus

Annuus ( Sunflower ) Seed Oil , Butyrospermum Parki Shea ) Butter ,

Squalane , Cocos Nucifera ( Coconut ) Oil , Tocopheryl

Acetate ( Vitamin E)

Keep Out of Reach of Children.

Keep out of reach of children . If swallowed , get medical

help or contact a Poison Control Center right away .


Structured Label Content

Uses

Uses

Helps prevent sunburn

Higher SPF gives more sunburn protection

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

Section 50567-7 (50567-7)

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 swallowed , get medical

help or contact a Poison Control Center right away .

Purpose

purpose: sunscreen

Stop Use (Stop use)

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 swallowed , get medical

help or contact a Poison Control Center right away .

Warnings

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 swallowed , get medical

help or contact a Poison Control Center right away .

Directions

Directions

Apply liberally 15 minutes before sun exposure

Reappl.

After 80 minutes of swimming or sweating

Immediately after towel drying

At least every 2 hours-

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 agng . 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-sleeved shirts , pants , hats , and sunglasses

Do Not Use (Do not use)

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 swallowed , get medical

help or contact a Poison Control Center right away .

Package Label

82723-004 TATTOO MINERAL SUNSCREEN STICK

Other Information

Other information

protect this product from excessive heat and direct sun

May stain some fabrics

Active Ingredients

Zinc Oxide 21.6%

Titanium Dioxide 23.9%

Inactive Ingredients

Inactive ingredient

Caprylic / Capric Triglyceride , Cetyl Ethylhexanoate , Silica ,

TriethoxycaprylIylsilane , Microcrystalline Wax , Synthetic Wax ,

Copernicia Cerifera ( Carnauba ) Wax , Simmondsia Chinensis ( Jojoba)

Seed Oil , Theobroma Cacao ( Cocoa ) Seed Butter , Helianthus

Annuus ( Sunflower ) Seed Oil , Butyrospermum Parki Shea ) Butter ,

Squalane , Cocos Nucifera ( Coconut ) Oil , Tocopheryl

Acetate ( Vitamin E)

Keep Out of Reach of Children. (Keep out of reach of children.)

Keep out of reach of children . If swallowed , get medical

help or contact a Poison Control Center right away .


Advanced Ingredient Data


Raw Label Data

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