bdf0a11d-3563-4b09-a430-f031709cb3f3

Drug Facts

Composition & Product

Active Ingredients

homosalate (2.02 g) octocrylene (1.35 g) octisalate (0.67 g) avobenzone (0.40 g)

Inactive Ingredients

propylheptyl caprylate octyldodecanol

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2021-05-01

Medication Information

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.

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

Sunscreen

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

Other Information

Protect this product from excessive heat and direct sun

Inactive Ingredients

PROPYLHEPTYL CAPRYLATE, OCTYLDODECANOL, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, POLYAMIDE-8, DICAPRYLYL CARBONATE, DIBUTYL LAUROYL GLUTAMIDE, DIBUTYL ETHYLHEXANOYL GLUTAMIDE, ACRYLATES COPOLYMER, SILICA SILYLATE, LITSEA CUBEBA FRUIT OIL, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, DEHYDROACETIC ACID, PELARGONIUM GRAVEOLENS OIL, CANARIUM LUZONICUM GUM NONVOLATILES, EUCALYPTUS GLOBULUS LEAF OIL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, ANTHEMIS NOBILIS FLOWER OIL, CITRUS AURANTIUM AMARA (BITTER ORANGE) FLOWER OIL, DIOSPYROS KAKI LEAF EXTRACT, GLYCERIN, AQUA/WATER/EAU, ECHIUM PLANTAGINEUM SEED OIL, CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES, PANCRATIUM MARITIMUM EXTRACT

Description

HOMOSALATE 13.5% OCTOCRYLENE 9.0% ETHYLHEXYL SALICYLATE 4.5% BUTYL METHOXYDIBENZOYLMETHANE 2.7%

Active Ingredients

HOMOSALATE 13.5%

OCTOCRYLENE 9.0%

ETHYLHEXYL SALICYLATE 4.5%

BUTYL METHOXYDIBENZOYLMETHANE 2.7%

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

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.

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

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

Other Information (Other information)

Protect this product from excessive heat and direct sun

Inactive Ingredients (INACTIVE INGREDIENTS)

PROPYLHEPTYL CAPRYLATE, OCTYLDODECANOL, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, POLYAMIDE-8, DICAPRYLYL CARBONATE, DIBUTYL LAUROYL GLUTAMIDE, DIBUTYL ETHYLHEXANOYL GLUTAMIDE, ACRYLATES COPOLYMER, SILICA SILYLATE, LITSEA CUBEBA FRUIT OIL, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, DEHYDROACETIC ACID, PELARGONIUM GRAVEOLENS OIL, CANARIUM LUZONICUM GUM NONVOLATILES, EUCALYPTUS GLOBULUS LEAF OIL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, ANTHEMIS NOBILIS FLOWER OIL, CITRUS AURANTIUM AMARA (BITTER ORANGE) FLOWER OIL, DIOSPYROS KAKI LEAF EXTRACT, GLYCERIN, AQUA/WATER/EAU, ECHIUM PLANTAGINEUM SEED OIL, CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES, PANCRATIUM MARITIMUM EXTRACT

Active Ingredients (ACTIVE INGREDIENTS)

HOMOSALATE 13.5%

OCTOCRYLENE 9.0%

ETHYLHEXYL SALICYLATE 4.5%

BUTYL METHOXYDIBENZOYLMETHANE 2.7%

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

[{"name": "HOMOSALATE", "unii": "V06SV4M95S", "classCode": "ACTIB", "strengthNumerator": "2.02", "strengthDenominator": "15", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "OCTOCRYLENE", "unii": "5A68WGF6WM", "classCode": "ACTIB", "strengthNumerator": "1.35", "strengthDenominator": "15", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "0.67", "strengthDenominator": "15", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "0.40", "strengthDenominator": "15", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "PROPYLHEPTYL CAPRYLATE", "unii": "991Z19V2OD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OCTYLDODECANOL", "unii": "461N1O614Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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": "Sunscreen", "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", "Other information": "Protect this product from excessive heat and direct sun", "ACTIVE INGREDIENTS": "HOMOSALATE 13.5% OCTOCRYLENE 9.0% ETHYLHEXYL SALICYLATE 4.5% BUTYL METHOXYDIBENZOYLMETHANE 2.7%", "INACTIVE INGREDIENTS": "PROPYLHEPTYL CAPRYLATE, OCTYLDODECANOL, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, POLYAMIDE-8, DICAPRYLYL CARBONATE, DIBUTYL LAUROYL GLUTAMIDE, DIBUTYL ETHYLHEXANOYL GLUTAMIDE, ACRYLATES COPOLYMER, SILICA SILYLATE, LITSEA CUBEBA FRUIT OIL, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, DEHYDROACETIC ACID, PELARGONIUM GRAVEOLENS OIL, CANARIUM LUZONICUM GUM NONVOLATILES, EUCALYPTUS GLOBULUS LEAF OIL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, ANTHEMIS NOBILIS FLOWER OIL, CITRUS AURANTIUM AMARA (BITTER ORANGE) FLOWER OIL, DIOSPYROS KAKI LEAF EXTRACT, GLYCERIN, AQUA/WATER/EAU, ECHIUM PLANTAGINEUM SEED OIL, 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."}