Drug Facts

Composition & Product

Active Ingredients

Octisalate (50 mg) Avobenzone (30 mg) Homosalate (26 mg) Octocrylene

Inactive Ingredients

Ascorbic Acid Docosanol Benzyl Alcohol Cetostearyl Alcohol Cetearyl Glucoside Cetyl Alcohol Dimethicone Dimethiconol (2000 Cst) Edetate Disodium Ethylparaben Glycerin Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Iodopropynyl Butylcarbamate Isohexadecane Methylparaben Panthenol Pentylene Glycol Niacinamide Polyethylene Glycol 200 Peg-4 Dilaurate Peg-4 Laurate Peg-100 Stearate High Density Polyethylene Polysorbate 60 Propylparaben Stearic Acid Stearyl Alcohol .alpha.-tocopherol Acetate Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2013-03-15

Medication Information

Purpose

SUNSCREEN

Description

OCTISALATE 5.0%, AVOBENZONE 3.0%, HOMOSALATE 3.0%, OCTOCRYLENE 2.6%

Use(s)

HELPS PREVENT SUNBURN. 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.

Warnings

FOR EXTERNAL USE ONLY.

Directions

APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE. USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING. REAPPLY AT LEAST EVERY 2 HOURS. CHILDREN UNDER 6 MONTHS: ASK A DOCTOR.

SUN PROTECTION MEASURES. SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANACER AND EARLY SKIN AGING. TO DECREASE THIS RISK, REGULARLY USE A SUNSCREEN WITH A BROAD SPECTRUM SPF VALUE 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-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.

Do Not Use

ON DAMAGED OR BROKEN SKIN.

Label Copy

Other Information

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

Active Ingredients

OCTISALATE 5.0%, AVOBENZONE 3.0%, HOMOSALATE 3.0%, OCTOCRYLENE 2.6%

Inactive Ingredients:

ASCORBIC ACID, BEHENYL ALCOHOL, BENZYL ALCOHOL, CETEARYL ALCOHOL, CETEARYL GLUCOSIDE, CETYL ALCOHOL, DIMETHICONE, DIMETHICONOL, DISODIUM EDTA, ETHYLPARABEN, FRAGRANCE (PARFUM), GLYCERIN, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, IODOPROPYNYL BUTYLCARBAMATE, ISOHEXADECANE, METHYLPARABEN, PANTHENOL, PENTYLENE GLYCOL, NIACINAMIDE, PEG-4, PEG-4 DILAURATE, PEG-4 LAURATE, PEG-100 STEARATE, POLYETHYLENE, POLYSORBATE 60, PROPYLPARABEN, STEARIC ACID, STEARYL ALCOHOL, TOCOPHERYL ACETATE, WATER (AQUA).

Questions Or Comments?

1-877-932-7948

When Using This Product

KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

Keep Out of Reach of Children

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Stop Using This Product and Ask A Doctor If

RASH OCCURS.

Structured Label Content

Use(s) (USE(S))

HELPS PREVENT SUNBURN. 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 (PURPOSE)

SUNSCREEN

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY.

Directions (DIRECTIONS)

APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE. USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING. REAPPLY AT LEAST EVERY 2 HOURS. CHILDREN UNDER 6 MONTHS: ASK A DOCTOR.

SUN PROTECTION MEASURES. SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANACER AND EARLY SKIN AGING. TO DECREASE THIS RISK, REGULARLY USE A SUNSCREEN WITH A BROAD SPECTRUM SPF VALUE 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-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.

Do Not Use (DO NOT USE)

ON DAMAGED OR BROKEN SKIN.

Label Copy (LABEL COPY)

Other Information (OTHER INFORMATION)

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

Active Ingredients (ACTIVE INGREDIENTS)

OCTISALATE 5.0%, AVOBENZONE 3.0%, HOMOSALATE 3.0%, OCTOCRYLENE 2.6%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

ASCORBIC ACID, BEHENYL ALCOHOL, BENZYL ALCOHOL, CETEARYL ALCOHOL, CETEARYL GLUCOSIDE, CETYL ALCOHOL, DIMETHICONE, DIMETHICONOL, DISODIUM EDTA, ETHYLPARABEN, FRAGRANCE (PARFUM), GLYCERIN, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, IODOPROPYNYL BUTYLCARBAMATE, ISOHEXADECANE, METHYLPARABEN, PANTHENOL, PENTYLENE GLYCOL, NIACINAMIDE, PEG-4, PEG-4 DILAURATE, PEG-4 LAURATE, PEG-100 STEARATE, POLYETHYLENE, POLYSORBATE 60, PROPYLPARABEN, STEARIC ACID, STEARYL ALCOHOL, TOCOPHERYL ACETATE, WATER (AQUA).

Questions Or Comments? (QUESTIONS OR COMMENTS?)

1-877-932-7948

When Using This Product (WHEN USING THIS PRODUCT)

KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Stop Using This Product and Ask A Doctor If (STOP USING THIS PRODUCT AND ASK A DOCTOR IF)

RASH OCCURS.

Advanced Ingredient Data

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"strengthDenominatorUnit": ""}, {"name": "IODOPROPYNYL BUTYLCARBAMATE", "unii": "603P14DHEB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOHEXADECANE", "unii": "918X1OUF1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PANTHENOL", "unii": "WV9CM0O67Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PENTYLENE GLYCOL", "unii": "50C1307PZG", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NIACINAMIDE", "unii": "25X51I8RD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 200", "unii": "R95B8J264J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-4 DILAURATE", "unii": "KCR71CW036", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-4 LAURATE", "unii": "AYF4VM3N1Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-100 STEARATE", "unii": "YD01N1999R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HIGH DENSITY POLYETHYLENE", "unii": "UG00KM4WR7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 60", "unii": "CAL22UVI4M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARYL ALCOHOL", "unii": "2KR89I4H1Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USE(S)": "HELPS PREVENT SUNBURN. 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", "WARNINGS": "FOR EXTERNAL USE ONLY.", "DIRECTIONS": "APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE. USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING. REAPPLY AT LEAST EVERY 2 HOURS. CHILDREN UNDER 6 MONTHS: ASK A DOCTOR. SUN PROTECTION MEASURES. SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANACER AND EARLY SKIN AGING. TO DECREASE THIS RISK, REGULARLY USE A SUNSCREEN WITH A BROAD SPECTRUM SPF VALUE 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-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.", "DO NOT USE": "ON DAMAGED OR BROKEN SKIN.", "OTHER INFORMATION": "PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.", "ACTIVE INGREDIENTS": "OCTISALATE 5.0%, AVOBENZONE 3.0%, HOMOSALATE 3.0%, OCTOCRYLENE 2.6%", "INACTIVE INGREDIENTS:": "ASCORBIC ACID, BEHENYL ALCOHOL, BENZYL ALCOHOL, CETEARYL ALCOHOL, CETEARYL GLUCOSIDE, CETYL ALCOHOL, DIMETHICONE, DIMETHICONOL, DISODIUM EDTA, ETHYLPARABEN, FRAGRANCE (PARFUM), GLYCERIN, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, IODOPROPYNYL BUTYLCARBAMATE, ISOHEXADECANE, METHYLPARABEN, PANTHENOL, PENTYLENE GLYCOL, NIACINAMIDE, PEG-4, PEG-4 DILAURATE, PEG-4 LAURATE, PEG-100 STEARATE, POLYETHYLENE, POLYSORBATE 60, PROPYLPARABEN, STEARIC ACID, STEARYL ALCOHOL, TOCOPHERYL ACETATE, WATER (AQUA).", "QUESTIONS OR COMMENTS?": "1-877-932-7948", "WHEN USING THIS PRODUCT": "KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.", "KEEP OUT OF REACH OF CHILDREN": "IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.", "STOP USING THIS PRODUCT AND ASK A DOCTOR IF": "RASH OCCURS."}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information