Drug Facts

Composition & Product

Active Ingredients

Avobenzone (2.5 g) Octisalate (5 g) Octocrylene (10 g)

Inactive Ingredients

Limonene, (+)- Safflower Oil Aloe Vera Leaf Tetrahexyldecyl Ascorbate Citric Acid Monohydrate Isododecane Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) .alpha.-tocopherol Acetate Squalane Butyloctyl Salicylate Dimethicone/divinyldimethicone/silsesquioxane Crosspolymer Camellia Oil Dimethicone Apricot Kernel Oil Orange Oil

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-01-06

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

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

Dosage and Administration

Directions • apply generously 15 minutes before sun exposure • children under 6 months of age: Ask a doctor • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • 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

Description

Active ingredients Avobenzone 2.5% Octisalate 5% Octocrylene 10%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin

Section 51727-6

Inactive ingredients ISODODECANE, POLYSILICONE-11, DIMETHICONE, SQUALANE, BUTYLOCTYL SALICYLATE, DIVINYLDIMETHICONE/DIMETHICONE/ PHENYLSILSESQUIOXANE CROSSPOLYMER, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, LIMONENE, CAMELLIA OLEIFERA SEED OIL, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, ALOE BARBADENSIS LEAF EXTRACT, PRUNUS ARMENIACA (APRICOT) KERNEL OIL, TETRAHEXYLDECYL ASCORBATE, TOCOPHERYL ACETATE, CITRIC ACID.

Section 51945-4

Section 55105-1

Purpose

Sunscreen

Section 55106-9

Active ingredients

Avobenzone 2.5%

Octisalate 5%

Octocrylene 10%

Section 60561-8

Other information • protect the product in this container from excessive heat and direct sun

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Directions • apply generously 15 minutes before sun exposure • children under 6 months of age: Ask a doctor • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • 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

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 51727-6 (51727-6)

Inactive ingredients ISODODECANE, POLYSILICONE-11, DIMETHICONE, SQUALANE, BUTYLOCTYL SALICYLATE, DIVINYLDIMETHICONE/DIMETHICONE/ PHENYLSILSESQUIOXANE CROSSPOLYMER, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, LIMONENE, CAMELLIA OLEIFERA SEED OIL, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, ALOE BARBADENSIS LEAF EXTRACT, PRUNUS ARMENIACA (APRICOT) KERNEL OIL, TETRAHEXYLDECYL ASCORBATE, TOCOPHERYL ACETATE, CITRIC ACID.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 55106-9 (55106-9)

Active ingredients

Avobenzone 2.5%

Octisalate 5%

Octocrylene 10%

Section 60561-8 (60561-8)

Other information • protect the product in this container from excessive heat and direct sun

Advanced Ingredient Data

[{"name": "LIMONENE, (+)-", "unii": "GFD7C86Q1W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SAFFLOWER OIL", "unii": "65UEH262IS", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TETRAHEXYLDECYL ASCORBATE", "unii": "9LBV3F07AZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISODODECANE", "unii": "A8289P68Y2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)", "unii": "9E4CO0W6C5", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "2.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "SQUALANE", "unii": "GW89575KF9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYLOCTYL SALICYLATE", "unii": "2EH13UN8D3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE/DIVINYLDIMETHICONE/SILSESQUIOXANE CROSSPOLYMER", "unii": "T3064TZ75A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAMELLIA OIL", "unii": "T1PE06G0VE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OCTOCRYLENE", "unii": "5A68WGF6WM", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "APRICOT KERNEL OIL", "unii": "54JB35T06A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ORANGE OIL", "unii": "AKN3KSD11B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "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", "34068-7": "Directions • apply generously 15 minutes before sun exposure • children under 6 months of age: Ask a doctor • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • 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", "34071-1": "Warnings For external use only", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if rash occurs", "50567-7": "When using this product keep out of eyes. Rinse with water to remove.", "50570-1": "Do not use on damaged or broken skin", "51727-6": "Inactive ingredients ISODODECANE, POLYSILICONE-11, DIMETHICONE, SQUALANE, BUTYLOCTYL SALICYLATE, DIVINYLDIMETHICONE/DIMETHICONE/ PHENYLSILSESQUIOXANE CROSSPOLYMER, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, LIMONENE, CAMELLIA OLEIFERA SEED OIL, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, ALOE BARBADENSIS LEAF EXTRACT, PRUNUS ARMENIACA (APRICOT) KERNEL OIL, TETRAHEXYLDECYL ASCORBATE, TOCOPHERYL ACETATE, CITRIC ACID.", "55105-1": "Purpose Sunscreen", "55106-9": "Active ingredients Avobenzone 2.5% Octisalate 5% Octocrylene 10%", "60561-8": "Other information • protect the product in this container from excessive heat and direct sun"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information