eeb3c173-b280-76e4-e053-2995a90a0e79

SPL v3
SPL
SPL Set ID eeb3c173-b280-76e4-e053-2995a90a0e79
Route
topical
Published
Effective Date 2022-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (6 g) titanium dioxide (4.3 g)
Inactive Ingredients
glycerin coconut oil glyceryl monostearate caprylyl glycol guava plumeria rubra flower passiflora incarnata fruit mango sodium chloride mica alkyl (c12-15) benzoate alcohol kukui nut oil papaya ethylhexylglycerin cetyl peg/ppg-10/1 dimethicone (hlb 2) phenoxyethanol water medium-chain triglycerides dimethicone bismuth oxychloride triethoxycaprylylsilane polyhydroxystearic acid (2300 mw) aluminum oxide propylene carbonate

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2022-10-01 Until 2027-10-01
Purpose

Sunscreen

Description

Titanium Dioxide 4.3%, Zinc Oxide 6.0% .

Medication Information

Warnings

For external use only.

May stain some fabrics and surfaces.

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

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 longsleeved shirts, pants, hats, and sunglasses

• children under 6 months: Ask a doctor.

Other Information

Protect this product from excessive heat and direct sun

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, C12‐15 Alkyl Benzoate, Glycerin, Dimethicone, Cetyl PEG/PPG‐10/1 Dimethicone, Lauryl PEG‐8 Dimethicone, VP/Eicosene Copolymer, Sodium Chloride, Cocos Nucifera (Coconut) Oil, Glyceryl Stearate, Polyhydroxystearic Acid, Alcohol Denat., Phenoxyethanol, Stearalkonium Bentonite, Caprylyl Glycol, Fragrance, Alumina, Mica, Propylene Carbonate, Aleurites Moluccanus Seed Oil, Ethylhexylglycerin, Triethoxycaprylylsilane, Titanium Dioxide, Magnesium Stearate, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Passiflora Incarnata Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Bismuth Oxychloride, Iron Oxides.

Description

Titanium Dioxide 4.3%, Zinc Oxide 6.0% .

Principal Display Panel

HAWAIIAN

TROPIC

SUNSCREEN LOTION

MINERAL FACE

SKIN NOURISHING TINTED MILK

COCONUT OIL

30

CRUELTY FREE | VEGAN

BROAD SPECTRUM SPF30 UVA/UVB

WATER RESISTANT (80 MINUTES)

1.7 FL. OZ (50 mL)

Do Not Use

on damaged or broken skin.

Active Ingredients

Titanium Dioxide 4.3%, Zinc Oxide 6.0% .

Questions Or Comments?

1-800-NO UV RAY, Mon-Fri

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

Warnings

For external use only.

May stain some fabrics and surfaces.

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

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 longsleeved shirts, pants, hats, and sunglasses

• children under 6 months: Ask a doctor.

Other Information

Protect this product from excessive heat and direct sun

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, C12‐15 Alkyl Benzoate, Glycerin, Dimethicone, Cetyl PEG/PPG‐10/1 Dimethicone, Lauryl PEG‐8 Dimethicone, VP/Eicosene Copolymer, Sodium Chloride, Cocos Nucifera (Coconut) Oil, Glyceryl Stearate, Polyhydroxystearic Acid, Alcohol Denat., Phenoxyethanol, Stearalkonium Bentonite, Caprylyl Glycol, Fragrance, Alumina, Mica, Propylene Carbonate, Aleurites Moluccanus Seed Oil, Ethylhexylglycerin, Triethoxycaprylylsilane, Titanium Dioxide, Magnesium Stearate, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Passiflora Incarnata Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Bismuth Oxychloride, Iron Oxides.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

HAWAIIAN

TROPIC

SUNSCREEN LOTION

MINERAL FACE

SKIN NOURISHING TINTED MILK

COCONUT OIL

30

CRUELTY FREE | VEGAN

BROAD SPECTRUM SPF30 UVA/UVB

WATER RESISTANT (80 MINUTES)

1.7 FL. OZ (50 mL)

Do Not Use (Do not use)

on damaged or broken skin.

Active Ingredients

Titanium Dioxide 4.3%, Zinc Oxide 6.0% .

Questions Or Comments? (Questions or Comments?)

1-800-NO UV RAY, Mon-Fri

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:42.589465 · Updated: 2026-03-14T23:13:27.116919