Drug Facts

Composition & Product

Active Ingredients

Octinoxate (230 mg) Avobenzone (140 mg) Petrolatum (10 mg)

Inactive Ingredients

Paraffin Isocetyl Stearate Lanolin .alpha.-tocopherol Acetate

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-06-20

Medication Information

Purpose

Sunscreen, Sunscreen, Skin Protectant

Description

Avobenzone (3.0%), Octinoxate (7.5%) Petrolatum (42.3%)

Uses

Helps prevent sunburn. if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early aging caused by the sun. helps prevent and temporarily protects chafed, chapped or cracked lips. Helps prevent and protect from the drying effects of wind and cold weather

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

Directions

Apply liberally 15 minutes before sun exposure. 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 the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. to 2 p.m. wear long-sleeve shirts, pants, hats and sunglasses. Children under 6 months: Ask a doctor.

Active Ingredient

Avobenzone (3.0%), Octinoxate (7.5%)

Petrolatum (42.3%)

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Beeswax, Cetyl Alcohol, Copernicia Cerifera (Carnauba) Wax, Flavor, Helianthus Annuus (Sunflower) Seed Oil, Isocetyl Stearate, Isopropyl Lanolate, Lanolin, Parraffin, Saccharin, Tocopheryl Acetate, Tocerpheryl Linoleate/Oleate.

Keep Out of Reach of Children

If 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 aging caused by the sun. helps prevent and temporarily protects chafed, chapped or cracked lips. Helps prevent and protect from the drying effects of wind and cold weather

Purpose

Sunscreen, Sunscreen, Skin Protectant

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

Directions

Apply liberally 15 minutes before sun exposure. 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 the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. to 2 p.m. wear long-sleeve shirts, pants, hats and sunglasses. Children under 6 months: Ask a doctor.

Active Ingredient (Active ingredient)

Avobenzone (3.0%), Octinoxate (7.5%)

Petrolatum (42.3%)

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Beeswax, Cetyl Alcohol, Copernicia Cerifera (Carnauba) Wax, Flavor, Helianthus Annuus (Sunflower) Seed Oil, Isocetyl Stearate, Isopropyl Lanolate, Lanolin, Parraffin, Saccharin, Tocopheryl Acetate, Tocerpheryl Linoleate/Oleate.

Keep Out of Reach of Children

If 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": "PARAFFIN", "unii": "I9O0E3H2ZE", "classCode": "IACT", "strengthNumerator": "230", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "ISOCETYL STEARATE", "unii": "3RJ7186O9W", "classCode": "IACT", "strengthNumerator": "140", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "LANOLIN", "unii": "7EV65EAW6H", "classCode": "IACT", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "75", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "ACTIB", "strengthNumerator": "423", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

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 aging caused by the sun. helps prevent and temporarily protects chafed, chapped or cracked lips. Helps prevent and protect from the drying effects of wind and cold weather", "Purpose": "Sunscreen, Sunscreen, Skin Protectant", "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", "Directions": "Apply liberally 15 minutes before sun exposure. 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 the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. to 2 p.m. wear long-sleeve shirts, pants, hats and sunglasses. Children under 6 months: Ask a doctor.", "Active ingredient": "Avobenzone (3.0%), Octinoxate (7.5%) Petrolatum (42.3%)", "Inactive Ingredients": "Aloe Barbadensis Leaf Extract, Beeswax, Cetyl Alcohol, Copernicia Cerifera (Carnauba) Wax, Flavor, Helianthus Annuus (Sunflower) Seed Oil, Isocetyl Stearate, Isopropyl Lanolate, Lanolin, Parraffin, Saccharin, Tocopheryl Acetate, Tocerpheryl Linoleate/Oleate.", "Keep Out of Reach of Children": "If swallowed get medical help or contact a Poison Control Center right away."}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information