DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Octinoxate (71.1 mg) Octisalate (45 mg) Oxybenzone (30 mg) Avobenzone (25 mg)

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2009-12-21

Medication Information

Warnings and Precautions

Warnings

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 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 Ingredient OCTINOXATE 7.11%, OCTISALATE 4.5%, OXYBENZONE 3.0%, AVOBENZONE 2.5%.......

Section 42229-5

Purpose

.....Sunscreen

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,PROPYLENE GLYCOL, C12-15 ALKYL BENZOATE, DIMETHICONE, GLYCERYL STEARATE, THIODIPROPIONIC ACID, RETINYL PALMITATE, TRITICUM VULGARE (WHEAT) GERM EXTRACT, SACCHAROMYCES/ZINC FERMENT, GLYCOLIC ACID, SALICYLIC ACID, PYRIDOXINE HCL,TOCOPHEROL, PALMITOYL OLIGOPEPTIDE,PALMITOYL TETRAPEPTIDE- 7, GLYCERIN, ALUMINUM STARCH OCTENYLSUCCINATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, SILICA, ISOHEXADECANE, ACRYLATES CROSSPOLYMER, PEG-100 STEARATE, CAPRYLYL GLYCOL, HYDROGENATED POLYISOBUTENE, HYDROXYETHYLCELLULOSE, XANTHAN GUM, CHOLETH-24, POLYSORBATE 60, CETETH-24, ISODODECANE, SORBITAN ISOSTEARATE, POLYSTYRENE/HYDROGENATED POLYISOPENTENE COPOLYMER, BUTYLENE GLYCOL, CARBOMER, POLYSORBATE 20, STEARETH-2, AMMONIUM HYDROXIDE, CETYL ALCOHOL, STEARIC ACID, DISODIUM EDTA, PHENOXYETHANOL, PARFUM/FRAGRANCE.

Section 51945-4

Section 53413-1

Questions or comments?

Call toll free 1-800-FOR-AVON

Section 55106-9

Active Ingredient

OCTINOXATE 7.11%, OCTISALATE 4.5%,

OXYBENZONE 3.0%, AVOBENZONE 2.5%.......

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 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 42229-5 (42229-5)

Purpose

.....Sunscreen

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,PROPYLENE GLYCOL, C12-15 ALKYL BENZOATE, DIMETHICONE, GLYCERYL STEARATE, THIODIPROPIONIC ACID, RETINYL PALMITATE, TRITICUM VULGARE (WHEAT) GERM EXTRACT, SACCHAROMYCES/ZINC FERMENT, GLYCOLIC ACID, SALICYLIC ACID, PYRIDOXINE HCL,TOCOPHEROL, PALMITOYL OLIGOPEPTIDE,PALMITOYL TETRAPEPTIDE- 7, GLYCERIN, ALUMINUM STARCH OCTENYLSUCCINATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, SILICA, ISOHEXADECANE, ACRYLATES CROSSPOLYMER, PEG-100 STEARATE, CAPRYLYL GLYCOL, HYDROGENATED POLYISOBUTENE, HYDROXYETHYLCELLULOSE, XANTHAN GUM, CHOLETH-24, POLYSORBATE 60, CETETH-24, ISODODECANE, SORBITAN ISOSTEARATE, POLYSTYRENE/HYDROGENATED POLYISOPENTENE COPOLYMER, BUTYLENE GLYCOL, CARBOMER, POLYSORBATE 20, STEARETH-2, AMMONIUM HYDROXIDE, CETYL ALCOHOL, STEARIC ACID, DISODIUM EDTA, PHENOXYETHANOL, PARFUM/FRAGRANCE.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

Call toll free 1-800-FOR-AVON

Section 55106-9 (55106-9)

Active Ingredient

OCTINOXATE 7.11%, OCTISALATE 4.5%,

OXYBENZONE 3.0%, AVOBENZONE 2.5%.......

Advanced Ingredient Data

[{"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "71.1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "45", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "OXYBENZONE", "unii": "95OOS7VE0Y", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "25", "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 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.", "42229-5": "Purpose .....Sunscreen", "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,PROPYLENE GLYCOL, C12-15 ALKYL BENZOATE, DIMETHICONE, GLYCERYL STEARATE, THIODIPROPIONIC ACID, RETINYL PALMITATE, TRITICUM VULGARE (WHEAT) GERM EXTRACT, SACCHAROMYCES/ZINC FERMENT, GLYCOLIC ACID, SALICYLIC ACID, PYRIDOXINE HCL,TOCOPHEROL, PALMITOYL OLIGOPEPTIDE,PALMITOYL TETRAPEPTIDE- 7, GLYCERIN, ALUMINUM STARCH OCTENYLSUCCINATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, SILICA, ISOHEXADECANE, ACRYLATES CROSSPOLYMER, PEG-100 STEARATE, CAPRYLYL GLYCOL, HYDROGENATED POLYISOBUTENE, HYDROXYETHYLCELLULOSE, XANTHAN GUM, CHOLETH-24, POLYSORBATE 60, CETETH-24, ISODODECANE, SORBITAN ISOSTEARATE, POLYSTYRENE/HYDROGENATED POLYISOPENTENE COPOLYMER, BUTYLENE GLYCOL, CARBOMER, POLYSORBATE 20, STEARETH-2, AMMONIUM HYDROXIDE, CETYL ALCOHOL, STEARIC ACID, DISODIUM EDTA, PHENOXYETHANOL, PARFUM/FRAGRANCE.", "53413-1": "Questions or comments? Call toll free 1-800-FOR-AVON", "55106-9": "Active Ingredient OCTINOXATE 7.11%, OCTISALATE 4.5%, OXYBENZONE 3.0%, AVOBENZONE 2.5%......."}