SPL v2
SPL
SPL Set ID fd5fc3ba-6e7c-4e48-8e65-47c03141df45
Route
TOPICAL
Published
Effective Date 2024-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (1.41 g)
Inactive Ingredients
Isopropyl Palmitate Ethylhexyl Palmitate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-05-01

Description

Titanium Dioxide 8.86%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 8.86%

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

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

• Apply liberally 15 minutes before sun exposure

• Reapply at least every 2 hours

• Use a water-resistant sunscreen if swimming or sweating

• 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 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

Active Ingredient

Titanium Dioxide 8.86%

Other Information

Protect this product from excessive heat and direct sun

Inactive Ingredients

ISOPROPYL PALMITATE, ETHYLHEXYL PALMITATE, POLYETHYLENE, SYNTHETIC FLUORPHLOGOPITE, C12-15 ALKYL BENZOATE, METHYL METHACRYLATE CROSSPOLYMER, POLYMETHYLSILSESQUIOXANE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, PHENYL TRIMETHICONE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CAPRYLYL METHICONE, OZOKERITE, VINYL DIMETHICONE, POLYHYDROXYSTEARIC ACID, CALAMINE, ALUMINUM STEARATE, ALUMINA, CITRUS AURANTIUM DULCIS (ORANGE) OIL, POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDR OXYSTEARATE/SEBACATE, TRIETHOXYCAPRYLYLSILANE, STEARIC ACID, CITRUS NOBILIS (MANDARIN ORANGE) PEEL OIL, DEHYDROACETIC ACID, LITSEA CUBEBA FRUIT OIL, OCTYLDODECANOL, DIOSPYROS KAKI LEAF EXTRACT, ECHIUM PLANTAGINEUM SEED OIL, GLYCERIN, AQUA/WATER/EAU, CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES, PANCRATIUM MARITIMUM EXTRACT

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

• 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)

Sunscreen

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

• Apply liberally 15 minutes before sun exposure

• Reapply at least every 2 hours

• Use a water-resistant sunscreen if swimming or sweating

• 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 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

Active Ingredient (ACTIVE INGREDIENT)

Titanium Dioxide 8.86%

Other Information (Other information)

Protect this product from excessive heat and direct sun

Inactive Ingredients (INACTIVE INGREDIENTS)

ISOPROPYL PALMITATE, ETHYLHEXYL PALMITATE, POLYETHYLENE, SYNTHETIC FLUORPHLOGOPITE, C12-15 ALKYL BENZOATE, METHYL METHACRYLATE CROSSPOLYMER, POLYMETHYLSILSESQUIOXANE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, PHENYL TRIMETHICONE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CAPRYLYL METHICONE, OZOKERITE, VINYL DIMETHICONE, POLYHYDROXYSTEARIC ACID, CALAMINE, ALUMINUM STEARATE, ALUMINA, CITRUS AURANTIUM DULCIS (ORANGE) OIL, POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDR OXYSTEARATE/SEBACATE, TRIETHOXYCAPRYLYLSILANE, STEARIC ACID, CITRUS NOBILIS (MANDARIN ORANGE) PEEL OIL, DEHYDROACETIC ACID, LITSEA CUBEBA FRUIT OIL, OCTYLDODECANOL, DIOSPYROS KAKI LEAF EXTRACT, ECHIUM PLANTAGINEUM SEED OIL, GLYCERIN, AQUA/WATER/EAU, CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES, PANCRATIUM MARITIMUM EXTRACT

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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