DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Octinoxate (75 mg) Octisalate (50 mg) Oxybenzone (47.5 mg) Avobenzone (30 mg)

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2013-02-09

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%, OCTISALATE 5.0%, OXYBENZONE 4.75%, AVOBENZONE 3.0%...............................................................

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, DIMETHICONE, ISODECYL ISONONANOATE, GLYCERIN, BUTYLENE GLYCOL, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, DILAURYL THIODIPROPIONATE, POLYMETHYL METHACRYLATE, THIODIPROPIONIC ACID, SALICYLIC ACID, ECLIPTA PROSTRATA EXTRACT, GOSSYPIUM HERBACEUM (COTTON) EXTRACT, PALMITOYL TETRAPEPTIDE-7, SODIUM HYALURONATE, PHYLLANTHUS EMBLICA FRUIT EXTRACT, FOENICULUM VULGARE (FENNEL) SEED EXTRACT, YEAST EXTRACT, SACCHAROMYCES LYSATE EXTRACT, KAEMPFERIA GALANGA ROOT EXTRACT, SACCHAROMYCES FERMENT FILTRATE, DIMETHICONE CROSSPOLYMER, SILICA, STEARETH-20, LACTOFERRIN, PHOSPHOLIPIDS, ISOHEXADECANE, HYDROGENATED LECITHIN, PHENOXYETHANOL, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, CARBOMER, TROMETHAMINE, POLYSORBATE 60, METHYLPARABEN, DISODIUM EDTA, PROPYLPARABEN, PARFUM/FRAGRANCE, MICA/CI 77019, TITANIUM DIOXIDE/CI 77891.

Section 51945-4

Section 53413-1

Questions? 1-800-FOR-AVON

Section 55105-1

Purpose

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

Section 55106-9

Active ingredients

OCTINOXATE 7.5%, OCTISALATE 5.0%,

OXYBENZONE 4.75%, AVOBENZONE 3.0%...............................................................

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, DIMETHICONE, ISODECYL ISONONANOATE, GLYCERIN, BUTYLENE GLYCOL, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, DILAURYL THIODIPROPIONATE, POLYMETHYL METHACRYLATE, THIODIPROPIONIC ACID, SALICYLIC ACID, ECLIPTA PROSTRATA EXTRACT, GOSSYPIUM HERBACEUM (COTTON) EXTRACT, PALMITOYL TETRAPEPTIDE-7, SODIUM HYALURONATE, PHYLLANTHUS EMBLICA FRUIT EXTRACT, FOENICULUM VULGARE (FENNEL) SEED EXTRACT, YEAST EXTRACT, SACCHAROMYCES LYSATE EXTRACT, KAEMPFERIA GALANGA ROOT EXTRACT, SACCHAROMYCES FERMENT FILTRATE, DIMETHICONE CROSSPOLYMER, SILICA, STEARETH-20, LACTOFERRIN, PHOSPHOLIPIDS, ISOHEXADECANE, HYDROGENATED LECITHIN, PHENOXYETHANOL, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, CARBOMER, TROMETHAMINE, POLYSORBATE 60, METHYLPARABEN, DISODIUM EDTA, PROPYLPARABEN, PARFUM/FRAGRANCE, MICA/CI 77019, TITANIUM DIOXIDE/CI 77891.

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%, OCTISALATE 5.0%,

OXYBENZONE 4.75%, AVOBENZONE 3.0%...............................................................

Advanced Ingredient Data

[{"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "75", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "OXYBENZONE", "unii": "95OOS7VE0Y", "classCode": "ACTIB", "strengthNumerator": "47.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "30", "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, DIMETHICONE, ISODECYL ISONONANOATE, GLYCERIN, BUTYLENE GLYCOL, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, DILAURYL THIODIPROPIONATE, POLYMETHYL METHACRYLATE, THIODIPROPIONIC ACID, SALICYLIC ACID, ECLIPTA PROSTRATA EXTRACT, GOSSYPIUM HERBACEUM (COTTON) EXTRACT, PALMITOYL TETRAPEPTIDE-7, SODIUM HYALURONATE, PHYLLANTHUS EMBLICA FRUIT EXTRACT, FOENICULUM VULGARE (FENNEL) SEED EXTRACT, YEAST EXTRACT, SACCHAROMYCES LYSATE EXTRACT, KAEMPFERIA GALANGA ROOT EXTRACT, SACCHAROMYCES FERMENT FILTRATE, DIMETHICONE CROSSPOLYMER, SILICA, STEARETH-20, LACTOFERRIN, PHOSPHOLIPIDS, ISOHEXADECANE, HYDROGENATED LECITHIN, PHENOXYETHANOL, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, CARBOMER, TROMETHAMINE, POLYSORBATE 60, METHYLPARABEN, DISODIUM EDTA, PROPYLPARABEN, PARFUM/FRAGRANCE, MICA/CI 77019, TITANIUM DIOXIDE/CI 77891.", "53413-1": "Questions? 1-800-FOR-AVON", "55105-1": "Purpose ...................................Sunscreen", "55106-9": "Active ingredients OCTINOXATE 7.5%, OCTISALATE 5.0%, OXYBENZONE 4.75%, AVOBENZONE 3.0%..............................................................."}