DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Octinoxate (71.1 mg) Octisalate (47.5 mg) Oxybenzone (40.0 mg) Avobenzone (28.5 mg)

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2009-12-15

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 7.11%, OCTISALATE 4.75%, OXYBENZONE 4.00%, AVOBENZONE 2.85%.............................................................

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, GLYCERIN, BUTYLENE GLYCOL,

ISODECYL ISONONANOATE, TROMETHAMINE, DILAURYL THIODIPROPIONATE, PHYTOL,

THIODIPROPIONIC ACID, THIAZOLYLALANINE, SESBANIA GRANDIFLORA FLOWER EXTRACT,

AMORPHOPHALLUS CAMPANULATUS RHIZOME/ROOT EXTRACT, PUNICA GRANATUM FRUIT

JUICE, PALMITOYL LYSYL AMINOVALEROYL LYSINE, TOCOPHEROL, POLYSORBATE 20,

CETEARYL ALCOHOL, KAEMPFERIA GALANGA ROOT EXTRACT, ISOHEXADECANE,

CARBOMER, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, NYLON-12,

POLYMETHYLSILSESQUIOXANE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL

TAURATE COPOLYMER, XANTHAN GUM, CETEARETH-20, HYDROGENATED LECITHIN, SILICA,

POLYSORBATE 60, TRIMETHYLSILOXYSILICATE, SORBITAN ISOSTEARATE, DIMETHICONE

CROSSPOLYMER, POLYMETHYL METHACRYLATE, ETHYLHEXYLGLYCERIN, DISODIUM EDTA,

PHENOXYETHANOL, PARFUM/FRAGRANCE.

Section 51945-4

Section 53413-1

Questions? Call 1-800-FOR-AVON

Section 55105-1

Purpose

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

Section 55106-9

Active ingredients

OCTINOXATE 7.11%, OCTISALATE 4.75%,

OXYBENZONE 4.00%, AVOBENZONE 2.85%.............................................................

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, GLYCERIN, BUTYLENE GLYCOL,

ISODECYL ISONONANOATE, TROMETHAMINE, DILAURYL THIODIPROPIONATE, PHYTOL,

THIODIPROPIONIC ACID, THIAZOLYLALANINE, SESBANIA GRANDIFLORA FLOWER EXTRACT,

AMORPHOPHALLUS CAMPANULATUS RHIZOME/ROOT EXTRACT, PUNICA GRANATUM FRUIT

JUICE, PALMITOYL LYSYL AMINOVALEROYL LYSINE, TOCOPHEROL, POLYSORBATE 20,

CETEARYL ALCOHOL, KAEMPFERIA GALANGA ROOT EXTRACT, ISOHEXADECANE,

CARBOMER, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, NYLON-12,

POLYMETHYLSILSESQUIOXANE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL

TAURATE COPOLYMER, XANTHAN GUM, CETEARETH-20, HYDROGENATED LECITHIN, SILICA,

POLYSORBATE 60, TRIMETHYLSILOXYSILICATE, SORBITAN ISOSTEARATE, DIMETHICONE

CROSSPOLYMER, POLYMETHYL METHACRYLATE, ETHYLHEXYLGLYCERIN, DISODIUM EDTA,

PHENOXYETHANOL, PARFUM/FRAGRANCE.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? Call 1-800-FOR-AVON

Section 55105-1 (55105-1)

Purpose

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

Section 55106-9 (55106-9)

Active ingredients

OCTINOXATE 7.11%, OCTISALATE 4.75%,

OXYBENZONE 4.00%, AVOBENZONE 2.85%.............................................................

Advanced Ingredient Data

[{"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "71.1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "47.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "OXYBENZONE", "unii": "95OOS7VE0Y", "classCode": "ACTIB", "strengthNumerator": "40.0", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "28.5", "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, GLYCERIN, BUTYLENE GLYCOL, ISODECYL ISONONANOATE, TROMETHAMINE, DILAURYL THIODIPROPIONATE, PHYTOL, THIODIPROPIONIC ACID, THIAZOLYLALANINE, SESBANIA GRANDIFLORA FLOWER EXTRACT, AMORPHOPHALLUS CAMPANULATUS RHIZOME/ROOT EXTRACT, PUNICA GRANATUM FRUIT JUICE, PALMITOYL LYSYL AMINOVALEROYL LYSINE, TOCOPHEROL, POLYSORBATE 20, CETEARYL ALCOHOL, KAEMPFERIA GALANGA ROOT EXTRACT, ISOHEXADECANE, CARBOMER, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, NYLON-12, POLYMETHYLSILSESQUIOXANE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, XANTHAN GUM, CETEARETH-20, HYDROGENATED LECITHIN, SILICA, POLYSORBATE 60, TRIMETHYLSILOXYSILICATE, SORBITAN ISOSTEARATE, DIMETHICONE CROSSPOLYMER, POLYMETHYL METHACRYLATE, ETHYLHEXYLGLYCERIN, DISODIUM EDTA, PHENOXYETHANOL, PARFUM/FRAGRANCE.", "53413-1": "Questions? Call 1-800-FOR-AVON", "55105-1": "Purpose .....................................Sunscreen", "55106-9": "Active ingredients OCTINOXATE 7.11%, OCTISALATE 4.75%, OXYBENZONE 4.00%, AVOBENZONE 2.85%............................................................."}