SPL v4
SPL
SPL Set ID efcd52c2-4208-46a1-e053-2a95a90a857d
Route
TOPICAL
Published
Effective Date 2022-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (6.7 g) Titanium Dioxide (4.9 g)
Inactive Ingredients
Alkyl (c12-15) Benzoate Dimethicone Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Aluminum Oxide Propylene Carbonate Mica Guava Plumeria Rubra Flower Papaya Kukui Nut Oil Ethylhexylglycerin Passiflora Incarnata Fruit Caprylyl Glycol Water Coconut Oil Ferric Oxide Yellow Glycerin Medium-chain Triglycerides Mango Triethoxycaprylylsilane Dehydrated Alcohol Sodium Chloride Phenoxyethanol Polyhydroxystearic Acid (2300 Mw) Stearyl/octyldodecyl Citrate Crosspolymer

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2022-10-01 Until 2027-10-01

Description

Titanium Dioxide 4.9%, Zinc Oxide 6.7% .

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 4.9%, Zinc Oxide 6.7% .

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 and surfaces.

Directions

• shake well • 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.

Do Not Use

on damaged or broken skin.

Other Information

Protect this product from excessive heat and direct sun

Active Ingredients

Titanium Dioxide 4.9%, Zinc Oxide 6.7% .

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Glycerin, Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, Stearyl/Octyldodecyl Citrate Crosspolymer, Polyhydroxystearic Acid, Alcohol Denat., Cocos Nucifera (Coconut) Oil, Sodium Chloride, Phenoxyethanol, Stearalkonium Bentonite, Caprylyl Glycol, Fragrance, Alumina, Propylene Carbonate, Ethylhexylglycerin, Aleurites Moluccanus Seed Oil, Triethoxycaprylylsilane, Mica, Titanium Dioxide, Psidium Guajava Fruit Extract,

Plumeria Acutifolia Flower Extract, Passiflora Incarnata Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Iron Oxides.

Questions Or Comments?

1-800-NO UV RAY, Mon-Fri

Principal Display Panel

HAWAIIAN

TROPIC

SUNSCREEN LOTION

MINERAL

SKIN NOURISHING MILK

50

CRUELTY FREE | VEGAN

BROAD SPECTRUM SPF 50 UVA/UVB

3.4 FL. OZ (100mL)

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

Warnings

For external use only.

May stain some fabrics and surfaces.

Directions

• shake well • 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.

Do Not Use (Do not use)

on damaged or broken skin.

Other Information

Protect this product from excessive heat and direct sun

Active Ingredients

Titanium Dioxide 4.9%, Zinc Oxide 6.7% .

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Glycerin, Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, Stearyl/Octyldodecyl Citrate Crosspolymer, Polyhydroxystearic Acid, Alcohol Denat., Cocos Nucifera (Coconut) Oil, Sodium Chloride, Phenoxyethanol, Stearalkonium Bentonite, Caprylyl Glycol, Fragrance, Alumina, Propylene Carbonate, Ethylhexylglycerin, Aleurites Moluccanus Seed Oil, Triethoxycaprylylsilane, Mica, Titanium Dioxide, Psidium Guajava Fruit Extract,

Plumeria Acutifolia Flower Extract, Passiflora Incarnata Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Iron Oxides.

Questions Or Comments? (Questions or Comments?)

1-800-NO UV RAY, Mon-Fri

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

HAWAIIAN

TROPIC

SUNSCREEN LOTION

MINERAL

SKIN NOURISHING MILK

50

CRUELTY FREE | VEGAN

BROAD SPECTRUM SPF 50 UVA/UVB

3.4 FL. OZ (100mL)

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)