Drug Facts

Composition & Product

Active Ingredients

Octinoxate (7.0 mg) Octocrylene (2 mg) Avobenzone (3.0 mg) Homosalate (8.0 mg)

Inactive Ingredients

Coconut Oil White Wax .alpha.-tocopherol Acetate Shea Butter Menthol Canola Oil

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2014-05-09

Medication Information

Purpose

Sunscreen

Description

Avobenzone (3.0%), Homosalate (8.0%), Octinoxate (7.0%), Octocrylene (2.0%)

Uses

Helps prevent sunburn.

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 AM – 2 PM . Wear long-sleeved shirts, pants, hats and sunglasses. Children under 6 months: Ask a doctor.

Active Ingredient

Avobenzone (3.0%), Homosalate (8.0%), Octinoxate (7.0%), Octocrylene (2.0%)

Inactive Ingredients

Canola Oil*, Beeswax*, Cocos Nucifera (Coconut) Oil*, Mentha Piperita (Peppermint)

Oil, Tocopherol, Lecithin*, Menthol, Camphor, Hippophae Rhamnoides Oil,

Butyrospermum Parkii (Shea Butter), Brassica Campestris (Rapeseed) Oil*, Hydrastis

Canadensis (Golden Seal) Root Extract*, Echinacea Purpurea Extract*, Calendula

Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*.

*

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.

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.

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 AM – 2 PM . Wear long-sleeved shirts, pants, hats and sunglasses. Children under 6 months: Ask a doctor.

Active Ingredient (Active ingredient)

Avobenzone (3.0%), Homosalate (8.0%), Octinoxate (7.0%), Octocrylene (2.0%)

Inactive Ingredients

Canola Oil*, Beeswax*, Cocos Nucifera (Coconut) Oil*, Mentha Piperita (Peppermint)

Oil, Tocopherol, Lecithin*, Menthol, Camphor, Hippophae Rhamnoides Oil,

Butyrospermum Parkii (Shea Butter), Brassica Campestris (Rapeseed) Oil*, Hydrastis

Canadensis (Golden Seal) Root Extract*, Echinacea Purpurea Extract*, Calendula

Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*.

*

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": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "7.0", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "OCTOCRYLENE", "unii": "5A68WGF6WM", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "3.0", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "HOMOSALATE", "unii": "V06SV4M95S", "classCode": "ACTIB", "strengthNumerator": "8.0", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "COCONUT OIL", "unii": "Q9L0O73W7L", "classCode": "IACT", "strengthNumerator": "17", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "WHITE WAX", "unii": "7G1J5DA97F", "classCode": "IACT", "strengthNumerator": "27", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "1.30", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "SHEA BUTTER", "unii": "K49155WL9Y", "classCode": "IACT", "strengthNumerator": ".1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "IACT", "strengthNumerator": ".3", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "CANOLA OIL", "unii": "331KBJ17RK", "classCode": "IACT", "strengthNumerator": "28", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Helps prevent sunburn.", "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.", "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 AM – 2 PM . Wear long-sleeved shirts, pants, hats and sunglasses. Children under 6 months: Ask a doctor.", "Active ingredient": "Avobenzone (3.0%), Homosalate (8.0%), Octinoxate (7.0%), Octocrylene (2.0%)", "Inactive Ingredients": "Canola Oil*, Beeswax*, Cocos Nucifera (Coconut) Oil*, Mentha Piperita (Peppermint) Oil, Tocopherol, Lecithin*, Menthol, Camphor, Hippophae Rhamnoides Oil, Butyrospermum Parkii (Shea Butter), Brassica Campestris (Rapeseed) Oil*, Hydrastis Canadensis (Golden Seal) Root Extract*, Echinacea Purpurea Extract*, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*. *", "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