6d95b59a-9af2-baa2-e053-2991aa0aaa24

Drug Facts

Composition & Product

Active Ingredients

octinoxate (75 mg) octisalate (47.5 mg) oxybenzone (40 mg) avobenzone (28.5 mg)

Inactive Ingredients

water trisiloxane myristyl myristate peg-100 stearate glycerin thiazolylalanine maltodextrin caprylyl glycol potassium hydroxide 1,2-hexanediol dimethicone stearic acid

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2016-03-01

Medication Information

Warnings and Precautions

Warnings

For external use only.

Active Ingredient

Active ingredients

OCTINOXATE 7.5%, OCTISALATE 4.75%,

OXYBENZONE 4.0%, AVOBENZONE 2.85%..................................

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 4.75%, OXYBENZONE 4.0%, AVOBENZONE 2.85%..................................

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, GLYCERIN, SILICA, DIMETHICONE, STEARIC ACID, STEARYL ALCOHOL, NONENOL, SAPINDUS RARAK FRUIT EXTRACT, POUZOLZIA PENTANDRA EXTRACT, METHOXYBENZOYL METHYLSULFONYL OXOPIPERIDINYL PIPERAZINECARBOXAMIDE, THIAZOLYLALANINE, SACCHAROMYCES/PLATINUM FERMENT, TRISILOXANE, DIMETHICONOL, MYRISTYL MYRISTATE, MALTODEXTRIN, PEG-100 STEARATE, CAPRYLYL GLYCOL,GLYCERYL STEARATE, SODIUM POLYACRYLATE, POLYURETHANE-40, POTASSIUM HYDROXIDE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, DISODIUM EDTA, 1,2-HEXANEDIOL, PARFUM.

Section 51945-4

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only.

Active Ingredient (55106-9)

Active ingredients

OCTINOXATE 7.5%, OCTISALATE 4.75%,

OXYBENZONE 4.0%, AVOBENZONE 2.85%..................................

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

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, GLYCERIN, SILICA, DIMETHICONE, STEARIC ACID, STEARYL ALCOHOL, NONENOL, SAPINDUS RARAK FRUIT EXTRACT, POUZOLZIA PENTANDRA EXTRACT, METHOXYBENZOYL METHYLSULFONYL OXOPIPERIDINYL PIPERAZINECARBOXAMIDE, THIAZOLYLALANINE, SACCHAROMYCES/PLATINUM FERMENT, TRISILOXANE, DIMETHICONOL, MYRISTYL MYRISTATE, MALTODEXTRIN, PEG-100 STEARATE, CAPRYLYL GLYCOL,GLYCERYL STEARATE, SODIUM POLYACRYLATE, POLYURETHANE-40, POTASSIUM HYDROXIDE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, DISODIUM EDTA, 1,2-HEXANEDIOL, PARFUM.

Section 51945-4 (51945-4)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

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