SPL v3
SPL
SPL Set ID b2b7c425-6c60-41cf-adea-9c355b24a443
Route
TOPICAL
Published
Effective Date 2017-09-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (4.9 mg) Titanium Dioxide (3.78 mg) Octisalate (3.5 mg) Zinc Cation (2.1 mg)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-10-01

Description

Active Ingredients: Ethylhexyl Methoxycinnamate 7.0%, Titanium Dioxide 5.4%, Ethylhexyl Salicylate 5.0%, Zinc Oxide 3.0%

Purpose

PURPOSE: SUNSCREEN


Medication Information

Purpose

PURPOSE: SUNSCREEN

Description

Active Ingredients: Ethylhexyl Methoxycinnamate 7.0%, Titanium Dioxide 5.4%, Ethylhexyl Salicylate 5.0%, Zinc Oxide 3.0%

Uses

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

Warnings:

For external use only

Do not use on damaged or broken skin.

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.

Directions

Directions:

- apply liberally 15 minutes before sun exposure

- reapply:

- after 40 minutes of swimming or sweating

- immediately after towel drying

- 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 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-sleeve shirts, pants, hats, and sunglasses

Active Ingredient

Active Ingredients: Ethylhexyl Methoxycinnamate 7.0%, Titanium Dioxide 5.4%, Ethylhexyl Salicylate 5.0%, Zinc Oxide 3.0%

Inactive Ingredient

Inactive Ingredients:

cyclomethicone, water, cyclopentasiloxane, glycerin, butylene glycol, alcohol, silica, mica, cyclohexasiloxane, PEG-10 dimethicone, cetyl PEG/PPG-10/1 dimethicone, sorbitan sesquioleate, hexyl laurate, dimethicone, caviar extract, Ginkgo biloba nut extract, Phellinus linteus extract, sodium hyaluronate, elemental sulfur, Aspalathus linearis extract, Potentilla erecta root extract, Scutellaria, baicalensis root extract, human oligopeptide-1, Thymus serpyllum extract, stearic acid, alumina, isostearic acid, triethoxycaprylylsilane, stearalkonium hectorite, disodium EDTA, fragrance, phenoxyethanol, BHT

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.

Package Label.principal Display Panel


Structured Label Content

Uses

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 (PURPOSE)

PURPOSE: SUNSCREEN

Warnings (WARNINGS)

Warnings:

For external use only

Do not use on damaged or broken skin.

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.

Directions

Directions:

- apply liberally 15 minutes before sun exposure

- reapply:

- after 40 minutes of swimming or sweating

- immediately after towel drying

- 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 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-sleeve shirts, pants, hats, and sunglasses

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredients: Ethylhexyl Methoxycinnamate 7.0%, Titanium Dioxide 5.4%, Ethylhexyl Salicylate 5.0%, Zinc Oxide 3.0%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients:

cyclomethicone, water, cyclopentasiloxane, glycerin, butylene glycol, alcohol, silica, mica, cyclohexasiloxane, PEG-10 dimethicone, cetyl PEG/PPG-10/1 dimethicone, sorbitan sesquioleate, hexyl laurate, dimethicone, caviar extract, Ginkgo biloba nut extract, Phellinus linteus extract, sodium hyaluronate, elemental sulfur, Aspalathus linearis extract, Potentilla erecta root extract, Scutellaria, baicalensis root extract, human oligopeptide-1, Thymus serpyllum extract, stearic acid, alumina, isostearic acid, triethoxycaprylylsilane, stearalkonium hectorite, disodium EDTA, fragrance, phenoxyethanol, BHT

Keep Out of Reach of Children (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.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)