1a7ec673-328a-8924-e063-6294a90a2f3d

SPL v2
SPL
SPL Set ID 1a7ec673-328a-8924-e063-6294a90a2f3d
Route
topical
Published
Effective Date 2024-06-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octisalate (4.5 g) titanium dioxide (3 g) homosalate (8.5 g) zinc cation (13 g)
Inactive Ingredients
water hexamethyldisiloxane cyclomethicone 5

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-05-01

Description

Active ingredient(s) ZINC OXIDE 13.00% HOMOSALATE 8.50% ETHYLHEXYL SALICYLATE 4.50% TITANIUM DIOXIDE 3.00%


Medication Information

Warnings and Precautions

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.

Active Ingredient

Active ingredient(s)

ZINC OXIDE 13.00%

HOMOSALATE 8.50%

ETHYLHEXYL SALICYLATE 4.50%

TITANIUM DIOXIDE 3.00%

Indications and Usage

Use(s)

■ 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

Dosage and Administration

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 againg. To decrease this risk, regularly use a sunscreen with SPF value of 15 or higher and other sun protection measures including:

■ Limit time in the sun, especially from 10a.m.-2p.m.

■ Wear long-sleeved shirts, pants, hats and sunglasses

Description

Active ingredient(s) ZINC OXIDE 13.00% HOMOSALATE 8.50% ETHYLHEXYL SALICYLATE 4.50% TITANIUM DIOXIDE 3.00%

Section 50565-1

■ Keep out of reach of children if product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive Ingredients

WATER, DISILOXANE, CYCLOPENTASILOXANE, BUTYLOCTYL SALICYLATE, ALCOHOL DENAT., POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE, BUTYLENE GLYCOL, NIACINAMIDE, PROPANEDIOL, METHYL METHACRYLATE CROSSPOLYMER, POLYMETHYLSILSESQUIOXANE, LAURYL PEG-10 TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE, SILICA, SODIUM CHLORIDE, 1,2-HEXANEDIOL, 3-O-ETHYL ASCORBIC ACID, ALUMINUM HYDROXIDE, STEARIC ACID, TRIETHOXYCAPRYLYLSILANE, FRAGRANCE, MELIA AZADIRACHTA FLOWER EXTRACT, MELIA AZADIRACHTA LEAF EXTRACT, CAPRYLYL GLYCOL, GLYCERYL CAPRYLATE, CURCUMA LONGA (TURMERIC) ROOT EXTRACT, OCIMUM SANCTUM LEAF EXTRACT, ASCORBIC ACID, ETHYLHEXYLGLYCERIN, CORALLINA OFFICINALIS EXTRACT, SODIUM HYALURONATE, TOCOPHEROL

Section 51945-4

Section 53413-1

Questions?

[email protected]

Section 55105-1

Purpose

Sunscreen

Section 60561-8

Other Information

■ Protect the product in this container from excessive heat and direct sun


Structured Label Content

Warnings and Precautions (34071-1)

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.

Active Ingredient (55106-9)

Active ingredient(s)

ZINC OXIDE 13.00%

HOMOSALATE 8.50%

ETHYLHEXYL SALICYLATE 4.50%

TITANIUM DIOXIDE 3.00%

Indications and Usage (34067-9)

Use(s)

■ 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

Dosage and Administration (34068-7)

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 againg. To decrease this risk, regularly use a sunscreen with SPF value of 15 or higher and other sun protection measures including:

■ Limit time in the sun, especially from 10a.m.-2p.m.

■ Wear long-sleeved shirts, pants, hats and sunglasses

Section 50565-1 (50565-1)

■ Keep out of reach of children if product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive Ingredients

WATER, DISILOXANE, CYCLOPENTASILOXANE, BUTYLOCTYL SALICYLATE, ALCOHOL DENAT., POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE, BUTYLENE GLYCOL, NIACINAMIDE, PROPANEDIOL, METHYL METHACRYLATE CROSSPOLYMER, POLYMETHYLSILSESQUIOXANE, LAURYL PEG-10 TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE, SILICA, SODIUM CHLORIDE, 1,2-HEXANEDIOL, 3-O-ETHYL ASCORBIC ACID, ALUMINUM HYDROXIDE, STEARIC ACID, TRIETHOXYCAPRYLYLSILANE, FRAGRANCE, MELIA AZADIRACHTA FLOWER EXTRACT, MELIA AZADIRACHTA LEAF EXTRACT, CAPRYLYL GLYCOL, GLYCERYL CAPRYLATE, CURCUMA LONGA (TURMERIC) ROOT EXTRACT, OCIMUM SANCTUM LEAF EXTRACT, ASCORBIC ACID, ETHYLHEXYLGLYCERIN, CORALLINA OFFICINALIS EXTRACT, SODIUM HYALURONATE, TOCOPHEROL

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions?

[email protected]

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 60561-8 (60561-8)

Other Information

■ Protect the product in this container from excessive heat and direct sun


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)