SPL v2
SPL
SPL Set ID 98c99242-b1e3-46be-9361-f91efd49cd80
Route
TOPICAL
Published
Effective Date 2017-09-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (2.8 mg) Octinoxate (2 mg)
Inactive Ingredients
Water Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-10-01

Description

Active Ingredients: Titanium Dioxide 7.0%, Octinoxate 5.0%

Purpose

PURPOSE: SUNSCREEN


Medication Information

Purpose

PURPOSE: SUNSCREEN

Description

Active Ingredients: Titanium Dioxide 7.0%, Octinoxate 5.0%

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

- use a water resistant product 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 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: Titanium Dioxide 7.0%, Octinoxate 5.0%

Inactive Ingredient

Inactive Ingredients:

aqua, propylene glycol, cetyl ethylhexanoate, glycerin, cetyl PEG/PPG-10/1 dimethicone, Macadamia integrifolia seed oil, Argania spinosa kernel oil, oligopeptide-1, caviar extract, portulaca oleracea extract, aloe barbadensis leaf extract, althaea rosea flower extract, butyrospermum parkii butter, sulfur, allantoin, collagen, dimethicone, CI 77492, CI 77491, CI 77499, stearyl dimethicone, sorbitan sesquioleate, butylene glycol, sodium chloride, talc, phenoxyethanol, parfum

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

- use a water resistant product 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 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: Titanium Dioxide 7.0%, Octinoxate 5.0%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients:

aqua, propylene glycol, cetyl ethylhexanoate, glycerin, cetyl PEG/PPG-10/1 dimethicone, Macadamia integrifolia seed oil, Argania spinosa kernel oil, oligopeptide-1, caviar extract, portulaca oleracea extract, aloe barbadensis leaf extract, althaea rosea flower extract, butyrospermum parkii butter, sulfur, allantoin, collagen, dimethicone, CI 77492, CI 77491, CI 77499, stearyl dimethicone, sorbitan sesquioleate, butylene glycol, sodium chloride, talc, phenoxyethanol, parfum

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

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