DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Octinoxate (3.24 g) Titanium Dioxide (3 g) Octisalate (2.04 g)

Inactive Ingredients

Water Cyclomethicone 5

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-10-01

Medication Information

Indications and Usage

Uses:

■ Helps prevent sun burn

■ 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

Dosage and Administration

Directions:

■ Apply generously and evenly 15-20 minutes before sun exposure.

■ Use a water resistant sunscreen if swimming or sweating.

■ Reapply every 1-2 hours after towel drying, swimming, or perspiring.

■ 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 15 or higher and other sun protection measures including:

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

- Wear long sleeve shirts, pants, hats, and sunglasses.

- Children under 6 months: Consult a doctor.

Description

Ethylhexyl Methoxycinnamate 5.40% Titanium Dioxide 5.00% Ethylhexyl Salicylate 3.40%

Section 50565-1

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

Section 51945-4

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

■ 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 or irritation develops.

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

Other Information

■ Protect this product from excessive heat and direct sun.

Active Ingredients

Ethylhexyl Methoxycinnamate 5.40%

Titanium Dioxide 5.00%

Ethylhexyl Salicylate 3.40%

Inactive Ingredients

Aqua, Cyclopentasiloxane, Silica, 4-Methylbenzylidene Camphor, Cyclohexasiloxane, Cetyl Ethylhexanoate, Sorbitan Isostearate, Glycerin,

Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Cetyl PEG/PPG-10/1 Dimethicone, Sodium Chloride, Calcium Stearate, Glyceryl Caprylate, Betaine, Beeswax, Allantoin, Ozokerite, Glyceryl Caprylate, Butylene Glycol, Aloe Barbadensis Leaf Juice Powder, Xanthan Gum, Triethoxycaprylylsilane, 1,2-Hexanediol, Sodium DNA, Ginkgo Biloba Leaf Extract, Ethylhexylglycerin, Lecithin, Polysorbate 20, sr-Rainbow Trout Oligopeptide-1 sh-Oligopeptide-1, sh-Oligopeptide-1.

Structured Label Content

Indications and Usage (34067-9)

Uses:

■ Helps prevent sun burn

■ 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 and evenly 15-20 minutes before sun exposure.

■ Use a water resistant sunscreen if swimming or sweating.

■ Reapply every 1-2 hours after towel drying, swimming, or perspiring.

■ 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 15 or higher and other sun protection measures including:

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

- Wear long sleeve shirts, pants, hats, and sunglasses.

- Children under 6 months: Consult a doctor.

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 51945-4 (51945-4)

Purpose (PURPOSE)

Sunscreen

Warnings (WARNINGS)

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

■ 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 or irritation develops.

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

Other Information

■ Protect this product from excessive heat and direct sun.

Active Ingredients (ACTIVE INGREDIENTS)

Ethylhexyl Methoxycinnamate 5.40%

Titanium Dioxide 5.00%

Ethylhexyl Salicylate 3.40%

Inactive Ingredients (INACTIVE INGREDIENTS)

Aqua, Cyclopentasiloxane, Silica, 4-Methylbenzylidene Camphor, Cyclohexasiloxane, Cetyl Ethylhexanoate, Sorbitan Isostearate, Glycerin,

Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Cetyl PEG/PPG-10/1 Dimethicone, Sodium Chloride, Calcium Stearate, Glyceryl Caprylate, Betaine, Beeswax, Allantoin, Ozokerite, Glyceryl Caprylate, Butylene Glycol, Aloe Barbadensis Leaf Juice Powder, Xanthan Gum, Triethoxycaprylylsilane, 1,2-Hexanediol, Sodium DNA, Ginkgo Biloba Leaf Extract, Ethylhexylglycerin, Lecithin, Polysorbate 20, sr-Rainbow Trout Oligopeptide-1 sh-Oligopeptide-1, sh-Oligopeptide-1.

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CYCLOMETHICONE 5", "unii": "0THT5PCI0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "3.24", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "2.04", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses: ■ Helps prevent sun burn ■ 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 and evenly 15-20 minutes before sun exposure. ■ Use a water resistant sunscreen if swimming or sweating. ■ Reapply every 1-2 hours after towel drying, swimming, or perspiring. ■ 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 15 or higher and other sun protection measures including: - Limit time in the sun, especially from 10a.m-2p.m. - Wear long sleeve shirts, pants, hats, and sunglasses. - Children under 6 months: Consult a doctor.", "50565-1": "■ Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center right away.", "PURPOSE": "Sunscreen", "WARNINGS": "Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging. ■ 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 or irritation develops. ■ Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center right away.", "Other Information": "■ Protect this product from excessive heat and direct sun.", "ACTIVE INGREDIENTS": "Ethylhexyl Methoxycinnamate 5.40% Titanium Dioxide 5.00% Ethylhexyl Salicylate 3.40%", "INACTIVE INGREDIENTS": "Aqua, Cyclopentasiloxane, Silica, 4-Methylbenzylidene Camphor, Cyclohexasiloxane, Cetyl Ethylhexanoate, Sorbitan Isostearate, Glycerin, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Cetyl PEG/PPG-10/1 Dimethicone, Sodium Chloride, Calcium Stearate, Glyceryl Caprylate, Betaine, Beeswax, Allantoin, Ozokerite, Glyceryl Caprylate, Butylene Glycol, Aloe Barbadensis Leaf Juice Powder, Xanthan Gum, Triethoxycaprylylsilane, 1,2-Hexanediol, Sodium DNA, Ginkgo Biloba Leaf Extract, Ethylhexylglycerin, Lecithin, Polysorbate 20, sr-Rainbow Trout Oligopeptide-1 sh-Oligopeptide-1, sh-Oligopeptide-1."}