Drug Facts

Composition & Product

Active Ingredients

Avobenzone (3 mL) Homosalate (8 mL) Octisalate (4 mL) Oxybenzone (5 mL)

Inactive Ingredients

Water Ascorbyl Palmitate Butylene Glycol Alkyl (c12-15) Benzoate C12-20 Alkyl Glucoside Medium-chain Triglycerides Carbomer Homopolymer Type C Crithmum Maritimum Cyclomethicone 5 Dimethicone Herring Sperm Dna Glycerin Glyceryl Monostearate Linalool, (+/-)- Magnesium Ascorbyl Phosphate Methylchloroisothiazolinone Phenoxyethanol Lecithin, Soybean Silicon Dioxide Tocopherol Triethanolamine Hydrochloride Trisiloxane Ulva Lactuca Undaria Pinnatifida Xanthan Gum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2012-03-01

Medication Information

Warnings and Precautions

For external use only • Do not use on damaged or broken skin

• Stop use and ask a doctor if rash occurs

Keep out of eyes, Rinse with water to remove. Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

Dosage and Administration

• For Sunscreen use

• Apply liberally 15 minutes before sun exposure

• Use water resistance sunscreen if swimming or sweating

• Reapply at least every 2 hours

• Children under 6 months: Ask a doctor

Description

Avobenzone 3.0% Homosalate 8.0% Octisalate 4.0% Oxybenzone 5.0%

Section 44425-7

Protect the product in this container from excessive heat

and direct sun

Section 50567-7

Helps prevent sunburn

If used as directed with other sun protection measures

(see directions) decreases the risk of skin cancers and early skin aging

Section 51727-6

Aqua/Water/Eau, Ascorbyl Tetraisopalmitate, Blue 1 (CI 42090), Butylene

Glycol, C12-15 Alkyl Benzoate, C12-20 Alkyl Glucoside, C14-22 Alcohols,

Caprylic/Capric Triglyceride, Carbomer, Crithmum Maritimum Extract,

Cyclopentasiloxane, Dimethicone, DNA, Ext. Violet 2 (CI 60730), Glycerin,

Glyceryl Stearate, Leuconostoc/Radish Root Ferment Filtrate, Linalool,

Magnesium Ascorbyl Phosphate, Methylisothiazolinone,

Parfum/Fragrance, Phenoxyethanol, Phospholipids, Silica, Tocopherol,

Triethanolamine, Trisiloxane, Ulva Lactuca Extract, Undaria Pinnatifida

Extract, Xanthan Gum

Section 51945-4

Image of Carton Label fa270.jpg

Section 55105-1

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Section 55106-9

Avobenzone 3.0%

Homosalate 8.0%

Octisalate 4.0%

Oxybenzone 5.0%

Structured Label Content

Dosage and Administration (34068-7)

• For Sunscreen use

• Apply liberally 15 minutes before sun exposure

• Use water resistance sunscreen if swimming or sweating

• Reapply at least every 2 hours

• Children under 6 months: Ask a doctor

Warnings and Precautions (34071-1)

For external use only • Do not use on damaged or broken skin

• Stop use and ask a doctor if rash occurs

Keep out of eyes, Rinse with water to remove. Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

Section 44425-7 (44425-7)

Protect the product in this container from excessive heat

and direct sun

Section 50567-7 (50567-7)

Helps prevent sunburn

If used as directed with other sun protection measures

(see directions) decreases the risk of skin cancers and early skin aging

Section 51727-6 (51727-6)

Aqua/Water/Eau, Ascorbyl Tetraisopalmitate, Blue 1 (CI 42090), Butylene

Glycol, C12-15 Alkyl Benzoate, C12-20 Alkyl Glucoside, C14-22 Alcohols,

Caprylic/Capric Triglyceride, Carbomer, Crithmum Maritimum Extract,

Cyclopentasiloxane, Dimethicone, DNA, Ext. Violet 2 (CI 60730), Glycerin,

Glyceryl Stearate, Leuconostoc/Radish Root Ferment Filtrate, Linalool,

Magnesium Ascorbyl Phosphate, Methylisothiazolinone,

Parfum/Fragrance, Phenoxyethanol, Phospholipids, Silica, Tocopherol,

Triethanolamine, Trisiloxane, Ulva Lactuca Extract, Undaria Pinnatifida

Extract, Xanthan Gum

Section 51945-4 (51945-4)

Image of Carton Label fa270.jpg

Section 55105-1 (55105-1)

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Section 55106-9 (55106-9)

Avobenzone 3.0%

Homosalate 8.0%

Octisalate 4.0%

Oxybenzone 5.0%

Advanced Ingredient Data

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""}, {"name": "GLYCERYL MONOSTEARATE", "unii": "230OU9XXE4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LINALOOL, (+/-)-", "unii": "D81QY6I88E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM ASCORBYL PHOSPHATE", "unii": "0R822556M5", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLCHLOROISOTHIAZOLINONE", "unii": "DEL7T5QRPN", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LECITHIN, SOYBEAN", "unii": "1DI56QDM62", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIETHANOLAMINE HYDROCHLORIDE", "unii": "R297UJ9QDY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRISILOXANE", "unii": "9G1ZW13R0G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ULVA LACTUCA", "unii": "PHR3P25W6Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "UNDARIA PINNATIFIDA", "unii": "ICV1OK7M1S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34068-7": "• For Sunscreen use • Apply liberally 15 minutes before sun exposure • Use water resistance sunscreen if swimming or sweating • Reapply at least every 2 hours • Children under 6 months: Ask a doctor", "34071-1": "For external use only • Do not use on damaged or broken skin • Stop use and ask a doctor if rash occurs Keep out of eyes, Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away", "44425-7": "Protect the product in this container from excessive heat and direct sun", "50567-7": "Helps prevent sunburn If used as directed with other sun protection measures (see directions) decreases the risk of skin cancers and early skin aging", "51727-6": "Aqua/Water/Eau, Ascorbyl Tetraisopalmitate, Blue 1 (CI 42090), Butylene Glycol, C12-15 Alkyl Benzoate, C12-20 Alkyl Glucoside, C14-22 Alcohols, Caprylic/Capric Triglyceride, Carbomer, Crithmum Maritimum Extract, Cyclopentasiloxane, Dimethicone, DNA, Ext. Violet 2 (CI 60730), Glycerin, Glyceryl Stearate, Leuconostoc/Radish Root Ferment Filtrate, Linalool, Magnesium Ascorbyl Phosphate, Methylisothiazolinone, Parfum/Fragrance, Phenoxyethanol, Phospholipids, Silica, Tocopherol, Triethanolamine, Trisiloxane, Ulva Lactuca Extract, Undaria Pinnatifida Extract, Xanthan Gum", "51945-4": "Image of Carton Label fa270.jpg", "55105-1": "Sunscreen Sunscreen Sunscreen Sunscreen", "55106-9": "Avobenzone 3.0% Homosalate 8.0% Octisalate 4.0% Oxybenzone 5.0%"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information