cdc54f23-0efb-2fb4-e053-2995a90ae58b

SPL v4
SPL
SPL Set ID cdc54f23-0efb-2fb4-e053-2995a90ae58b
Route
topical
Published
Effective Date 2021-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (24.5 g)
Inactive Ingredients
medium-chain triglycerides ascorbyl palmitate ferric oxide yellow ethylhexylglycerin ceramide np ferrosoferric oxide mango plumeria rubra flower calcium aluminum borosilicate triethoxycaprylylsilane guava silicon dioxide sodium dehydroacetate ferric oxide red sea salt papaya passiflora incarnata fruit

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2021-11-15

Purpose

Sunscreen Agent

Description

Zinc Oxide 24.5%


Medication Information

Purpose

Sunscreen Agent

Other Information

Protect this product from excessive heat and direct sun.

Description

Zinc Oxide 24.5%

Principal Display Panel

HAWAIIAN

Tropic (R)

MINERAL

TRANSLUCENT SUNSCREEN POWDER

30

BROAD SPECTRUM SPF 30

0.15 OZ. (4.25 g)

Carton

TRANSLUCENT

SUNSCREEN POWDER

WON'T CLOG PORES

DERM TESTED

VEGAN

HAWAIIAN

Tropic (R)

MINERAL

TRANSLUCENT SUNSCREEN POWDER

30

BROAD SPECTRUM SPF 30

0.15 OZ. (4.25 g)

Uses:

• Helps prevent sunburn •If used as directed with other sun protection measures (see Directions), decreases the risk of cancer and

early skin aging caused by the sun

Warnings:

For external use only.

Do Not Use

on damaged or broken skin.

Directions:

• Apply liberally 15 minutes before sun exposure. • Use a water resistant sunscreen if swimming or sweating. • Reapply at least every 2 hours. • Children under 6 months: 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 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

Active Ingredients:

Zinc Oxide 24.5%

Inactive Ingredients:

Calcium Aluminum Borosilicate, Silica, Ethylhexylglycerin, Sodium Dehydroacetate, Fragrance, Sea Salt, Ceramide NP, Ascorbyl

Palmitate, Caprylic/Capric Triglyceride, Triethoxycaprylylsilane, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Iron Oxides.

Questions Or Comments?

1- 800- NO UV RAY, Mon-Fri

When Using This Product:

Avoid inhalation. 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

Purpose

Sunscreen Agent

Other Information

Protect this product from excessive heat and direct sun.

Principal Display Panel

HAWAIIAN

Tropic (R)

MINERAL

TRANSLUCENT SUNSCREEN POWDER

30

BROAD SPECTRUM SPF 30

0.15 OZ. (4.25 g)

Carton

TRANSLUCENT

SUNSCREEN POWDER

WON'T CLOG PORES

DERM TESTED

VEGAN

HAWAIIAN

Tropic (R)

MINERAL

TRANSLUCENT SUNSCREEN POWDER

30

BROAD SPECTRUM SPF 30

0.15 OZ. (4.25 g)

Uses:

• Helps prevent sunburn •If used as directed with other sun protection measures (see Directions), decreases the risk of cancer and

early skin aging caused by the sun

Warnings:

For external use only.

Do Not Use (Do not use)

on damaged or broken skin.

Directions:

• Apply liberally 15 minutes before sun exposure. • Use a water resistant sunscreen if swimming or sweating. • Reapply at least every 2 hours. • Children under 6 months: 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 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

Active Ingredients:

Zinc Oxide 24.5%

Inactive Ingredients:

Calcium Aluminum Borosilicate, Silica, Ethylhexylglycerin, Sodium Dehydroacetate, Fragrance, Sea Salt, Ceramide NP, Ascorbyl

Palmitate, Caprylic/Capric Triglyceride, Triethoxycaprylylsilane, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Iron Oxides.

Questions Or Comments? (Questions or Comments?)

1- 800- NO UV RAY, Mon-Fri

When Using This Product: (When using this product:)

Avoid inhalation. 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.


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Raw Label Data

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