DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Octinoxate (75 mg) Octisalate (50 mg) Oxybenzone (10 mg)

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2013-02-27

Medication Information

Warnings and Precautions

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 help prevent sunburn, not skin cancer or early skin aging.

For external use only

Indications and Usage

Uses

helps prevent sunburn

Dosage and Administration

Directions

apply generously and evenly 15 minutes before sun exposure
children under 6 month of age:ask a doctor
reapply at least every 2 hours
use a water resistant sunscreen if swimming or sweating

Description

Active Ingredients Octinoxate, 7.5%............. Octisalate, 5.0%............... Oxybenzone, 1.0% ..............

Section 44425-7

Other Information

protect the product in this container from excessive heat and direct sun.

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin

Section 51727-6

Inactive ingredients:

WATER/EAU, GLYCERIN, BUTYLENE GLYCOL, GLYCERYL STEARATE, PEG-8, SILICA, CETYL ALCOHOL, IMIDAZOLIDINYL UREA, METHYLPARABEN, CARBOMER, DIMETHICONE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, DISODIUM EDTA, HYDROGENATED LECITHIN, PARFUM/FRAGRANCE, SODIUM HYDROXIDE, POLYGLYCERYL-3 DIISOSTEARATE, ORYZA SATIVA (RICE) BRAN OIL, DIMETHICONOL, HYDROGENATED POLYISOBUTENE, ASCORBYL PALMITATE, PANTHENOL, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, TOCOPHERYL ACETATE,

RETINYL PALMITATE, GLYCINE SOJA (SOYBEAN) STEROLS, LECITHIN, GLYCINE SOJA (SOYBEAN) OIL, TOCOPHEROL.

Section 51945-4

Section 53413-1

Questions or comments?

Call 1-800-FOR-AVON or 1-800-265-AVON in Canada.

Section 55105-1

Purpose

............... Sunscreen

............... Sunscreen

.............. Sunscreen

Section 55106-9

Active Ingredients

Octinoxate, 7.5%.............

Octisalate, 5.0%...............

Oxybenzone, 1.0% ..............

Structured Label Content

Indications and Usage (34067-9)

Uses

helps prevent sunburn

Dosage and Administration (34068-7)

Directions

apply generously and evenly 15 minutes before sun exposure
children under 6 month of age:ask a doctor
reapply at least every 2 hours
use a water resistant sunscreen if swimming or sweating

Warnings and Precautions (34071-1)

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 help prevent sunburn, not skin cancer or early skin aging.

For external use only

Section 44425-7 (44425-7)

Other Information

protect the product in this container from excessive heat and direct sun.

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 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 51727-6 (51727-6)

Inactive ingredients:

WATER/EAU, GLYCERIN, BUTYLENE GLYCOL, GLYCERYL STEARATE, PEG-8, SILICA, CETYL ALCOHOL, IMIDAZOLIDINYL UREA, METHYLPARABEN, CARBOMER, DIMETHICONE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, DISODIUM EDTA, HYDROGENATED LECITHIN, PARFUM/FRAGRANCE, SODIUM HYDROXIDE, POLYGLYCERYL-3 DIISOSTEARATE, ORYZA SATIVA (RICE) BRAN OIL, DIMETHICONOL, HYDROGENATED POLYISOBUTENE, ASCORBYL PALMITATE, PANTHENOL, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, TOCOPHERYL ACETATE,

RETINYL PALMITATE, GLYCINE SOJA (SOYBEAN) STEROLS, LECITHIN, GLYCINE SOJA (SOYBEAN) OIL, TOCOPHEROL.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

Call 1-800-FOR-AVON or 1-800-265-AVON in Canada.

Section 55105-1 (55105-1)

Purpose

............... Sunscreen

............... Sunscreen

.............. Sunscreen

Section 55106-9 (55106-9)

Active Ingredients

Octinoxate, 7.5%.............

Octisalate, 5.0%...............

Oxybenzone, 1.0% ..............

Advanced Ingredient Data

[{"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "75", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "OXYBENZONE", "unii": "95OOS7VE0Y", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses helps prevent sunburn", "34068-7": "Directions apply generously and evenly 15 minutes before sun exposure children under 6 month of age:ask a doctor reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating", "34071-1": "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 help prevent sunburn, not skin cancer or early skin aging. For external use only", "44425-7": "Other Information protect the product in this container from excessive heat and direct sun.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if rash occurs", "50567-7": "When using this product keep out of eyes. Rinse with water to remove.", "50570-1": "Do not use on damaged or broken skin", "51727-6": "Inactive ingredients: WATER/EAU, GLYCERIN, BUTYLENE GLYCOL, GLYCERYL STEARATE, PEG-8, SILICA, CETYL ALCOHOL, IMIDAZOLIDINYL UREA, METHYLPARABEN, CARBOMER, DIMETHICONE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, DISODIUM EDTA, HYDROGENATED LECITHIN, PARFUM/FRAGRANCE, SODIUM HYDROXIDE, POLYGLYCERYL-3 DIISOSTEARATE, ORYZA SATIVA (RICE) BRAN OIL, DIMETHICONOL, HYDROGENATED POLYISOBUTENE, ASCORBYL PALMITATE, PANTHENOL, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, TOCOPHERYL ACETATE, RETINYL PALMITATE, GLYCINE SOJA (SOYBEAN) STEROLS, LECITHIN, GLYCINE SOJA (SOYBEAN) OIL, TOCOPHEROL.", "53413-1": "Questions or comments? Call 1-800-FOR-AVON or 1-800-265-AVON in Canada.", "55105-1": "Purpose ............... Sunscreen ............... Sunscreen .............. Sunscreen", "55106-9": "Active Ingredients Octinoxate, 7.5%............. Octisalate, 5.0%............... Oxybenzone, 1.0% .............."}