DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Octinoxate (75 mg) Oxybenzone (40 mg) Avobenzone (20 mg)

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2012-11-11

Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and Usage

Uses

• 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

Dosage and Administration

Directions

• apply liberally 15 minutes before sun exposure

• children under 6 months of age: ask a doctor

• reapply at least every 2 hours

• use a water resistant sunscreen if swimming or sweating

• 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 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

Description

Active ingredients OCTINOXATE 7.5%, OXYBENZONE 4.0%, AVOBENZONE 2.0%.......................

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, PENTAERYTHRITYL TETRAETHYLHEXANOATE, STEARETH-2, GLYCOLIC ACID, BEHENYL ALCOHOL, DIMETHICONE, PEG-40 STEARATE, MYRISTYL MYRISTATE, TRISILOXANE, LAURYL LACTATE, ASPARTIC ACID, ZEA MAYS (CORN) KERNEL EXTRACT, PHYTOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, COLA NITIDA SEED EXTRACT, GLYCINE SOJA (SOYBEAN) SEED EXTRACT, PUNICA GRANATUM FRUIT JUICE, RETINYL PALMITATE, DAUCUS CAROTA SATIVA (CARROT) ROOT EXTRACT, ASCORBYL PALMITATE, HELIANTHUS ANNUUS (SUNFLOWER) SEED EXTRACT, RETINOL, GLYCINE SOJA (SOYBEAN) OIL, SAXIFRAGA SARMENTOSA EXTRACT, VITIS VINIFERA (GRAPE) FRUIT EXTRACT, TOCOPHEROL, BETA-CAROTENE, MORUS NIGRA ROOT EXTRACT, SCUTELLARIA BAICALENSIS ROOT EXTRACT, GLYCERYL STEARATE, PEG-100 STEARATE, PVM/MA DECADIENE CROSSPOLYMER, XANTHAN GUM, SILICA, ACRYLATES/CARBAMATE COPOLYMER, MALTODEXTRIN, LECITHIN, TRIMETHYLSILOXYSILICATE, BUTYLENE GLYCOL, AMMONIUM HYDROXIDE, PHENOXYETHANOL, METHYLPARABEN, DISODIUM EDTA, BHT, PARFUM/FRAGRANCE.

Section 51945-4

Section 53413-1

Questions? 1-800-FOR-AVON

Section 55105-1

Purpose

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

Section 55106-9

Active ingredients OCTINOXATE 7.5%, OXYBENZONE 4.0%,

AVOBENZONE 2.0%.......................

Structured Label Content

Indications and Usage (34067-9)

Uses

• 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

Dosage and Administration (34068-7)

Directions

• apply liberally 15 minutes before sun exposure

• children under 6 months of age: ask a doctor

• reapply at least every 2 hours

• use a water resistant sunscreen if swimming or sweating

• 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 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

Warnings and Precautions (34071-1)

Warnings

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, PENTAERYTHRITYL TETRAETHYLHEXANOATE, STEARETH-2, GLYCOLIC ACID, BEHENYL ALCOHOL, DIMETHICONE, PEG-40 STEARATE, MYRISTYL MYRISTATE, TRISILOXANE, LAURYL LACTATE, ASPARTIC ACID, ZEA MAYS (CORN) KERNEL EXTRACT, PHYTOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, COLA NITIDA SEED EXTRACT, GLYCINE SOJA (SOYBEAN) SEED EXTRACT, PUNICA GRANATUM FRUIT JUICE, RETINYL PALMITATE, DAUCUS CAROTA SATIVA (CARROT) ROOT EXTRACT, ASCORBYL PALMITATE, HELIANTHUS ANNUUS (SUNFLOWER) SEED EXTRACT, RETINOL, GLYCINE SOJA (SOYBEAN) OIL, SAXIFRAGA SARMENTOSA EXTRACT, VITIS VINIFERA (GRAPE) FRUIT EXTRACT, TOCOPHEROL, BETA-CAROTENE, MORUS NIGRA ROOT EXTRACT, SCUTELLARIA BAICALENSIS ROOT EXTRACT, GLYCERYL STEARATE, PEG-100 STEARATE, PVM/MA DECADIENE CROSSPOLYMER, XANTHAN GUM, SILICA, ACRYLATES/CARBAMATE COPOLYMER, MALTODEXTRIN, LECITHIN, TRIMETHYLSILOXYSILICATE, BUTYLENE GLYCOL, AMMONIUM HYDROXIDE, PHENOXYETHANOL, METHYLPARABEN, DISODIUM EDTA, BHT, PARFUM/FRAGRANCE.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? 1-800-FOR-AVON

Section 55105-1 (55105-1)

Purpose

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

Section 55106-9 (55106-9)

Active ingredients OCTINOXATE 7.5%, OXYBENZONE 4.0%,

AVOBENZONE 2.0%.......................

Advanced Ingredient Data

[{"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "75", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "OXYBENZONE", "unii": "95OOS7VE0Y", "classCode": "ACTIB", "strengthNumerator": "40", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses • 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", "34068-7": "Directions • apply liberally 15 minutes before sun exposure • children under 6 months of age: ask a doctor • reapply at least every 2 hours • use a water resistant sunscreen if swimming or sweating • 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 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", "34071-1": "Warnings 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, PENTAERYTHRITYL TETRAETHYLHEXANOATE, STEARETH-2, GLYCOLIC ACID, BEHENYL ALCOHOL, DIMETHICONE, PEG-40 STEARATE, MYRISTYL MYRISTATE, TRISILOXANE, LAURYL LACTATE, ASPARTIC ACID, ZEA MAYS (CORN) KERNEL EXTRACT, PHYTOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, COLA NITIDA SEED EXTRACT, GLYCINE SOJA (SOYBEAN) SEED EXTRACT, PUNICA GRANATUM FRUIT JUICE, RETINYL PALMITATE, DAUCUS CAROTA SATIVA (CARROT) ROOT EXTRACT, ASCORBYL PALMITATE, HELIANTHUS ANNUUS (SUNFLOWER) SEED EXTRACT, RETINOL, GLYCINE SOJA (SOYBEAN) OIL, SAXIFRAGA SARMENTOSA EXTRACT, VITIS VINIFERA (GRAPE) FRUIT EXTRACT, TOCOPHEROL, BETA-CAROTENE, MORUS NIGRA ROOT EXTRACT, SCUTELLARIA BAICALENSIS ROOT EXTRACT, GLYCERYL STEARATE, PEG-100 STEARATE, PVM/MA DECADIENE CROSSPOLYMER, XANTHAN GUM, SILICA, ACRYLATES/CARBAMATE COPOLYMER, MALTODEXTRIN, LECITHIN, TRIMETHYLSILOXYSILICATE, BUTYLENE GLYCOL, AMMONIUM HYDROXIDE, PHENOXYETHANOL, METHYLPARABEN, DISODIUM EDTA, BHT, PARFUM/FRAGRANCE.", "53413-1": "Questions? 1-800-FOR-AVON", "55105-1": "Purpose ................................Sunscreen", "55106-9": "Active ingredients OCTINOXATE 7.5%, OXYBENZONE 4.0%, AVOBENZONE 2.0%......................."}