c8d6c731-2dfc-71c0-e053-2a95a90aa5b8

SPL v4
SPL
SPL Set ID c8d6c731-2dfc-71c0-e053-2a95a90aa5b8
Route
topical
Published
Effective Date 2021-08-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (15 g)
Inactive Ingredients
water isododecane coconut oil aloe vera leaf titanium dioxide papaya plumeria rubra flower butyloctyl salicylate cetyl peg/ppg-10/1 dimethicone (hlb 2) phenoxyethanol triethoxycaprylylsilane stearyl/octyldodecyl citrate crosspolymer anhydrous trisodium citrate mango glycerin mica passiflora incarnata fruit guava kukui nut oil ferric oxide yellow polyhydroxystearic acid (2300 mw) .alpha.-tocopherol acetate

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2021-10-01 Until 2026-10-31

Purpose

Sunscreen

Description

Zinc Oxide 15.0%


Medication Information

Warnings

• For external use only.

Flammable: Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking.

May stain some fabrics.

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

• 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.

Other Information

Protect this product from excessive heat and direct sun

Inactive Ingredients

Water, Isododecane, Butyloctyl Salicylate, Cetyl PEG/PPG-10/1 Dimethicone, Stearyl/Octyldodecyl Citrate Crosspolymer, Cocos Nucifera (Coconut) Oil, Phenoxyethanol, Polyhydroxystearic Acid, Fragrance, Triethoxycaprylylsilane, Aleurites Moluccanus Seed Oil, Tocopheryl Acetate, Sodium Citrate, Aloe Barbadensis Leaf Juice, Glycerin, Mica, Titanium Dioxide, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Iron Oxides.

Description

Zinc Oxide 15.0%

Principal Display Panel

NEW

HAWAIIAN

TROPIC(R)

MINERAL

SKIN NOURISHING

MILK

30

SUNSCREEN BROAD SPECTRUM SPF30

UVA/UVB

OXYBENZONE & OCTINOXATE FREE

CRUELTY-FREE

SHAKE WELL BEFORE USE

3.4 FL. OZ. (100 mL)

Do Not Use

on damaged or broken skin.

Active Ingredients

Zinc Oxide 15.0%

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.

Flammable: Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking.

May stain some fabrics.

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

• 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.

Other Information

Protect this product from excessive heat and direct sun

Inactive Ingredients

Water, Isododecane, Butyloctyl Salicylate, Cetyl PEG/PPG-10/1 Dimethicone, Stearyl/Octyldodecyl Citrate Crosspolymer, Cocos Nucifera (Coconut) Oil, Phenoxyethanol, Polyhydroxystearic Acid, Fragrance, Triethoxycaprylylsilane, Aleurites Moluccanus Seed Oil, Tocopheryl Acetate, Sodium Citrate, Aloe Barbadensis Leaf Juice, Glycerin, Mica, Titanium Dioxide, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Iron Oxides.

Principal Display Panel

NEW

HAWAIIAN

TROPIC(R)

MINERAL

SKIN NOURISHING

MILK

30

SUNSCREEN BROAD SPECTRUM SPF30

UVA/UVB

OXYBENZONE & OCTINOXATE FREE

CRUELTY-FREE

SHAKE WELL BEFORE USE

3.4 FL. OZ. (100 mL)

Do Not Use (Do not use)

on damaged or broken skin.

Active Ingredients

Zinc Oxide 15.0%

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)