DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Titanium Dioxide (2.61 g) Octocrylene (1.80 g) Homosalate (0.90 g) Octisalate (0.54 g) Avobenzone

Inactive Ingredients

Isopropyl Myristate Ceresin

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2017-12-01

Medication Information

Purpose

Purpose: Sunscreen

Description

USES:

- Help prevent sunburn

- Higher SPF gives more sunburn protection

- Retains SPF after 180 minutes of activity in the water or sweating

DIRECTION: Apply liberally and uniformly to all exposed areas before sun exposure.

Warnings

WARNINGS :

FOR EXTERNAL USE ONLY

Do not use on damaged or broken skin

When using this product, Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away

Active Ingredient

Active ingredients: Titanium Dioxide 14.55%, Octocrylene 10.00%, Homosalate 10.00%, Ethylhexyl Salicylate 5.00%, Butyl Methoxydibenzoylmethane 3.00%

Inactive Ingredient

Inactive Ingredients:

Isopropyl Myristate, Triethyl Citrate , Ceresin, Talc, Methyl Methacrylate Crosspolymer, Euphorbia Cerifera (Candelilla) Wax, Cetyl Ethyhexanoate, CI 77492, Microcrystalline Wax, Polyethylene, Beeswax, Bis-EthylHexylOxyphenol Methoxyphenyl Triazine, CI 77491, Dimethicone, Silica Dimethyl Silylate , Ci 77499, Phenoxyethanol

Package Label.principal Display Panel

Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Warnings (WARNINGS)

WARNINGS :

FOR EXTERNAL USE ONLY

Do not use on damaged or broken skin

When using this product, Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away

Description (DESCRIPTION)

USES:

- Help prevent sunburn

- Higher SPF gives more sunburn protection

- Retains SPF after 180 minutes of activity in the water or sweating

DIRECTION: Apply liberally and uniformly to all exposed areas before sun exposure.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Titanium Dioxide 14.55%, Octocrylene 10.00%, Homosalate 10.00%, Ethylhexyl Salicylate 5.00%, Butyl Methoxydibenzoylmethane 3.00%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients:

Isopropyl Myristate, Triethyl Citrate , Ceresin, Talc, Methyl Methacrylate Crosspolymer, Euphorbia Cerifera (Candelilla) Wax, Cetyl Ethyhexanoate, CI 77492, Microcrystalline Wax, Polyethylene, Beeswax, Bis-EthylHexylOxyphenol Methoxyphenyl Triazine, CI 77491, Dimethicone, Silica Dimethyl Silylate , Ci 77499, Phenoxyethanol

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Advanced Ingredient Data

[{"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "ACTIB", "strengthNumerator": "2.61", "strengthDenominator": "18", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "OCTOCRYLENE", "unii": "5A68WGF6WM", "classCode": "ACTIB", "strengthNumerator": "1.80", "strengthDenominator": "18", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "HOMOSALATE", "unii": "V06SV4M95S", "classCode": "ACTIB", "strengthNumerator": "1.80", "strengthDenominator": "18", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "0.90", "strengthDenominator": "18", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "0.54", "strengthDenominator": "18", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "Isopropyl Myristate", "unii": "0RE8K4LNJS", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Ceresin", "unii": "Q1LS2UJO3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"PURPOSE": "Purpose: Sunscreen", "WARNINGS": "WARNINGS : FOR EXTERNAL USE ONLY Do not use on damaged or broken skin When using this product, Keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away", "DESCRIPTION": "USES: - Help prevent sunburn - Higher SPF gives more sunburn protection - Retains SPF after 180 minutes of activity in the water or sweating DIRECTION: Apply liberally and uniformly to all exposed areas before sun exposure.", "ACTIVE INGREDIENT": "Active ingredients: Titanium Dioxide 14.55%, Octocrylene 10.00%, Homosalate 10.00%, Ethylhexyl Salicylate 5.00%, Butyl Methoxydibenzoylmethane 3.00%", "INACTIVE INGREDIENT": "Inactive Ingredients: Isopropyl Myristate, Triethyl Citrate , Ceresin, Talc, Methyl Methacrylate Crosspolymer, Euphorbia Cerifera (Candelilla) Wax, Cetyl Ethyhexanoate, CI 77492, Microcrystalline Wax, Polyethylene, Beeswax, Bis-EthylHexylOxyphenol Methoxyphenyl Triazine, CI 77491, Dimethicone, Silica Dimethyl Silylate , Ci 77499, Phenoxyethanol"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information