SPL v1
SPL
SPL Set ID 2a71b781-85bf-476b-9d61-6ade59808272
Route
TOPICAL
Published
Effective Date 2014-07-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (2.70 g) Octinoxate (2.50 g) Titanium Dioxide (2.36 g) Octisalate (1.75 g)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-06-01

Description

Active ingredient: ZINC OXIDE 5.41%, ETHYLHEXYL METHOXYCINNAMATE 5.00%, TITANIUM DIOXIDE 4.73%, ETHYLHEXYL SALICYLATE 3.50%

Purpose

PURPOSE: Sunscreen


Medication Information

Purpose

PURPOSE: Sunscreen

Description

Active ingredient: ZINC OXIDE 5.41%, ETHYLHEXYL METHOXYCINNAMATE 5.00%, TITANIUM DIOXIDE 4.73%, ETHYLHEXYL SALICYLATE 3.50%

Use

USE:

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

Warning: Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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 at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. 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 long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months of age: Ask a doctor.

Active Ingredient

Active ingredient: ZINC OXIDE 5.41%, ETHYLHEXYL METHOXYCINNAMATE 5.00%, TITANIUM DIOXIDE 4.73%, ETHYLHEXYL SALICYLATE 3.50%

Inactive Ingredient

Inactive ingredient:

WATER, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, CYCLOHEXASILOXANE, PEG-10 DIMETHICONE, PHENYL TRIMETHICONE, NIACINAMIDE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, TRIMETHYLSILOXYSILICATE, SODIUM CHLORIDE, DISTEARDIMONIUM HECTORITE, ALUMINUM HYDROXIDE, SORBITAN ISOSTEARATE, PROPYLENE GLYCOL, ALOE BARBADENSIS LEAF EXTRACT, STEARIC ACID, BEESWAX, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER , DIMETHICONE, ALUMINA, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, ETHYLHEXYLGLYCERIN, OZOKERITE, TALC, PROPYLENE CARBONATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SILICA SILYLATE, TRIETHOXYCAPRYLYLSILANE, DIMETHICONE/METHICONE COPOLYMER, HYALURONIC ACID, SILICA, ADENOSINE, PHENOXYETHANOL, FRAGRANCE, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77492), IRON OXIDES (CI 77491), IRON OXIDES (CI 77499)

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel


Structured Label Content

Use (USE)

USE:

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)

Warning: Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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)

DIRECTIONS:

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. 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 long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months of age: Ask a doctor.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredient: ZINC OXIDE 5.41%, ETHYLHEXYL METHOXYCINNAMATE 5.00%, TITANIUM DIOXIDE 4.73%, ETHYLHEXYL SALICYLATE 3.50%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredient:

WATER, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, CYCLOHEXASILOXANE, PEG-10 DIMETHICONE, PHENYL TRIMETHICONE, NIACINAMIDE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, TRIMETHYLSILOXYSILICATE, SODIUM CHLORIDE, DISTEARDIMONIUM HECTORITE, ALUMINUM HYDROXIDE, SORBITAN ISOSTEARATE, PROPYLENE GLYCOL, ALOE BARBADENSIS LEAF EXTRACT, STEARIC ACID, BEESWAX, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER , DIMETHICONE, ALUMINA, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, ETHYLHEXYLGLYCERIN, OZOKERITE, TALC, PROPYLENE CARBONATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SILICA SILYLATE, TRIETHOXYCAPRYLYLSILANE, DIMETHICONE/METHICONE COPOLYMER, HYALURONIC ACID, SILICA, ADENOSINE, PHENOXYETHANOL, FRAGRANCE, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77492), IRON OXIDES (CI 77491), IRON OXIDES (CI 77499)

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

KEEP OUT OF REACH OF CHILDREN

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


Advanced Ingredient Data


Raw Label Data

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