SPL v3
SPL
SPL Set ID 05bbe530-df26-e598-e063-6394a90a0c59
Route
TOPICAL
Published
Effective Date 2023-09-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (23.8 g)
Inactive Ingredients
Shea Butter Silicon Dioxide Ceresin Butyloctyl Salicylate Microcrystalline Wax Mineral Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-01

Description

Zinc Oxide 23.8%

Purpose

Sunscreen Agent


Medication Information

Purpose

Sunscreen Agent

Description

Zinc Oxide 23.8%

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

May stain some fabrics.

Directions

• apply liberally 15 minutes before sun exposure • reapply: after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • 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 SPF 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 • children under 6 months: Ask a doctor

Do Not Use

on damaged or broken skin.

Other Information

• protect this product from excessive heat and direct sun

Active Ingredients

Zinc Oxide 23.8%

Inactive Ingredients

Mineral Oil, Ozokerite, Butyloctyl Salicylate, Microcrystalline Wax, Butyrospermum Parkii (Shea) Butter, Silica.

Questions Or Comments?

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

BANANA BOAT(R)

baby

mineral

SUNSCREEN STICK

UVA/UVB BROAD SPECTRUM SPF 50

50

Water

Resistant

(80 Minutes)

0.5 OZ. (14.2g)

93040707

FREE FROM

Oxybenzone

Octinoxate

50

BANANA BOAT(R)

WONT

RUN INTO

EYES

PEDIATRICIAN

TESTED

baby

mineral

SUNSCREEN STICK

UVA/UVB BROAD SPECTRUM SPF 50

No Added

Dyes &

Fragrances

0.5 OZ.

(14.2.g)

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.


Structured Label Content

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

Purpose

Sunscreen Agent

Warnings

For external use only

May stain some fabrics.

Directions

• apply liberally 15 minutes before sun exposure • reapply: after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • 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 SPF 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 • children under 6 months: Ask a doctor

Do Not Use (Do not use)

on damaged or broken skin.

Other Information (Other information)

• protect this product from excessive heat and direct sun

Active Ingredients

Zinc Oxide 23.8%

Inactive Ingredients

Mineral Oil, Ozokerite, Butyloctyl Salicylate, Microcrystalline Wax, Butyrospermum Parkii (Shea) Butter, Silica.

Questions Or Comments? (Questions or comments?)

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

BANANA BOAT(R)

baby

mineral

SUNSCREEN STICK

UVA/UVB BROAD SPECTRUM SPF 50

50

Water

Resistant

(80 Minutes)

0.5 OZ. (14.2g)

93040707

FREE FROM

Oxybenzone

Octinoxate

50

BANANA BOAT(R)

WONT

RUN INTO

EYES

PEDIATRICIAN

TESTED

baby

mineral

SUNSCREEN STICK

UVA/UVB BROAD SPECTRUM SPF 50

No Added

Dyes &

Fragrances

0.5 OZ.

(14.2.g)

When Using This Product (When using this product)

• Keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs.

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

If product is swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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