DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Avobenzone (3 g) Homosalate (12 g) Octisalate (5 g) Octocrylene

Inactive Ingredients

Butylated Hydroxytoluene Levomenol Butylene Glycol Alkyl (c12-15) Benzoate Capryloyl Glycine Caprylyl Glycol Cedrus Atlantica Bark Cinnamon Bark Oil Cyclomethicone 5 Edetate Disodium Ethylhexyl Stearate Ethylhexylglycerin Yeast Mannan Neopentyl Glycol Diheptanoate Phenoxyethanol Polyester-7 Propylene Glycol Purslane Sarcosine Steareth-2 Steareth-100 Trideceth-6 Phosphate Water Xanthan Gum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2013-04-10

Medication Information

Indications and Usage

Uses • helps prevent sunburn

Purpose

Avobenzone 3%, Homosalate 12%, Octisalate 5%, Octocrylene 3%.........................................................Sunscreen

Description

Avobenzone 3%, Homosalate 12%, Octisalate 5%, Octocrylene 3%.........................................................Sunscreen

Section 51945-4

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: • 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 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-sleeve shirts, pants, hats, and sunglasses

• children under 6 months: Ask a doctor

Other Information

• protect this product from excessive heat and direct sun • may stain fabrics.

Questions or comments?

1-800-Wegmans(934-6267) Ext 5920

9am - 4pm EST weekdays.

Inactive Ingredients

Acrylates/Dimethicone Copolymer

BHT

Bisabolol

Butylene Glycol

C12-15 Alkyl Benzoate

Capryloyl Glycine

Caprylyl Glycol

Cedrus Atlantica Bark Extract

Cetyl Dimethicone

Chlorphenesin

Cinnamomum Zeylanicum Bark Extract

Cyclopentasiloxane

Disodium EDTA

Ethylhexyl Stearate

Ethylhexylglycerin

Mannan

Neopentyl Glycol Diheptanoate

Phenoxyethanol

Polyester-7

Polyester-8

Portulaca Oleracea Extract

Propylene Glycol

Sarcosine

Silica

Sodium Polyacrylate

Steareth-2

Steareth-100

Styrene/Acrylates Copolymer

Trideceth-6

Water

Xanthan Gum

Active Ingredients Purpose

Avobenzone 3%, Homosalate 12%,

Octisalate 5%, Octocrylene 3%.........................................................Sunscreen

Structured Label Content

Indications and Usage (34067-9)

Uses • helps prevent sunburn

Section 51945-4 (51945-4)

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: • 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 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-sleeve shirts, pants, hats, and sunglasses

• children under 6 months: Ask a doctor

Other Information (Other information)

• protect this product from excessive heat and direct sun • may stain fabrics.

Questions or comments?

1-800-Wegmans(934-6267) Ext 5920

9am - 4pm EST weekdays.

Inactive Ingredients (Inactive ingredients)

Acrylates/Dimethicone Copolymer

BHT

Bisabolol

Butylene Glycol

C12-15 Alkyl Benzoate

Capryloyl Glycine

Caprylyl Glycol

Cedrus Atlantica Bark Extract

Cetyl Dimethicone

Chlorphenesin

Cinnamomum Zeylanicum Bark Extract

Cyclopentasiloxane

Disodium EDTA

Ethylhexyl Stearate

Ethylhexylglycerin

Mannan

Neopentyl Glycol Diheptanoate

Phenoxyethanol

Polyester-7

Polyester-8

Portulaca Oleracea Extract

Propylene Glycol

Sarcosine

Silica

Sodium Polyacrylate

Steareth-2

Steareth-100

Styrene/Acrylates Copolymer

Trideceth-6

Water

Xanthan Gum

Active Ingredients Purpose (Active ingredients Purpose)

Avobenzone 3%, Homosalate 12%,

Octisalate 5%, Octocrylene 3%.........................................................Sunscreen

Advanced Ingredient Data

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"YEAST MANNAN", "unii": "91R887N59P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Neopentyl Glycol Diheptanoate", "unii": "5LKW3C543X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Phenoxyethanol", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Polyester-7", "unii": "0841698D2F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Propylene Glycol", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PURSLANE", "unii": "M6S840WXG5", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sarcosine", "unii": "Z711V88R5F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Steareth-2", "unii": "V56DFE46J5", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Steareth-100", "unii": "4OH5W9UM87", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIDECETH-6 PHOSPHATE", "unii": "NKT96BX1OC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Xanthan Gum", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "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 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: • 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 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-sleeve shirts, pants, hats, and sunglasses • children under 6 months: Ask a doctor", "Other information": "• protect this product from excessive heat and direct sun • may stain fabrics. Questions or comments? 1-800-Wegmans(934-6267) Ext 5920 9am - 4pm EST weekdays.", "Inactive ingredients": " Acrylates/Dimethicone Copolymer BHT Bisabolol Butylene Glycol C12-15 Alkyl Benzoate Capryloyl Glycine Caprylyl Glycol Cedrus Atlantica Bark Extract Cetyl Dimethicone Chlorphenesin Cinnamomum Zeylanicum Bark Extract Cyclopentasiloxane Disodium EDTA Ethylhexyl Stearate Ethylhexylglycerin Mannan Neopentyl Glycol Diheptanoate Phenoxyethanol Polyester-7 Polyester-8 Portulaca Oleracea Extract Propylene Glycol Sarcosine Silica Sodium Polyacrylate Steareth-2 Steareth-100 Styrene/Acrylates Copolymer Trideceth-6 Water Xanthan Gum", "Active ingredients Purpose": "Avobenzone 3%, Homosalate 12%, Octisalate 5%, Octocrylene 3%.........................................................Sunscreen"}