Bl1408

Drug Facts

Composition & Product

Active Ingredients

Petrolatum (1.117 g) Padimate O (0.296 g) Oxybenzone (0.111 g)

Inactive Ingredients

Castor Oil Myristyl Lactate Candelilla Wax Yellow Wax Microcrystalline Wax Butylparaben Propylparaben Butylated Hydroxytoluene Alpha-tocopherol Corn Oil

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH FINAL Active Since 2006-03-28

Medication Information

Indications and Usage

To Use: Apply liberally as often as necessary.

Purpose

SPF 15 protects against UV exposure.

Description

Moisturizes, softens and smooths lips. Provides antioxidant protection with vitamin E. SPF 15 protects against UV exposure. Provides a sheer wash of color in 6 translucent shades. Dermatologist, clinically and allergy tested.

Warnings

Warning: If condition worsens or does not improve within 7 days, consult a physician.

Otc Purpose

SPF 15 protects against UV exposure.

Otc When Using

Note condition.

Inactive Ingredient

Other Ingredients: Ozokerite, Ricinus Communis (Castor) Seed Oil, Glyceryl Rosinate, Cetyl Lactate, Lanolin Oil, Myristyl Lactate, Cetyl Acetate, Euphorbia Cerifera (Candelilla) Wax/Candelilla Cera/Cire De Candelilla, Copernicia Cerifera (Carnauba) Wax/Cer Carnauba/Cire De Carnauba, Beeswax/Cera Alba/Cire D'Abeille, Tocopherol, Acetylated Lanolin Alcohol, Methylstyrene/Vinyltoluene Copolymer, Microcrystalline Wax/Cera Microcristallina/Cire Microcristalline, BHT, Vegetable Oil/Olus/Huile Vegetale, Zea Mays (Corn) Oil, Citral Citronellol, Geraniol, Limonene, Linalool, Butylparaben, Propylparaben.

May Contain: Blue 1 Lake (CI 42090), Iron Oxides (CI 77491, CI 77499, CI 77492), Red 6 Lake (CI 15850), Red 7 Lake (CI 15850), Red 21 Lake (CI 45380), Red 27 Lake (CI 45410), Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140), Yellow 6 Lake (CI15985).

Dosage & Administration

Apply to lips.

Otc Active Ingredient

Active Ingredients: Petrolatum, 30.2% w/w, Padimate O, 8.0% w/w, Oxybenzone, 3.0% w/w.

Otc Keep Out of Reach of Children

Keep out of reach of children.

Package Label.principal Display Panel

Structured Label Content

Warnings (WARNINGS)

Warning: If condition worsens or does not improve within 7 days, consult a physician.

Description (DESCRIPTION)

Moisturizes, softens and smooths lips. Provides antioxidant protection with vitamin E. SPF 15 protects against UV exposure. Provides a sheer wash of color in 6 translucent shades. Dermatologist, clinically and allergy tested.

Otc Purpose (OTC - PURPOSE)

SPF 15 protects against UV exposure.

Otc When Using (OTC - WHEN USING)

Note condition.

Inactive Ingredient (INACTIVE INGREDIENT)

Other Ingredients: Ozokerite, Ricinus Communis (Castor) Seed Oil, Glyceryl Rosinate, Cetyl Lactate, Lanolin Oil, Myristyl Lactate, Cetyl Acetate, Euphorbia Cerifera (Candelilla) Wax/Candelilla Cera/Cire De Candelilla, Copernicia Cerifera (Carnauba) Wax/Cer Carnauba/Cire De Carnauba, Beeswax/Cera Alba/Cire D'Abeille, Tocopherol, Acetylated Lanolin Alcohol, Methylstyrene/Vinyltoluene Copolymer, Microcrystalline Wax/Cera Microcristallina/Cire Microcristalline, BHT, Vegetable Oil/Olus/Huile Vegetale, Zea Mays (Corn) Oil, Citral Citronellol, Geraniol, Limonene, Linalool, Butylparaben, Propylparaben.

May Contain: Blue 1 Lake (CI 42090), Iron Oxides (CI 77491, CI 77499, CI 77492), Red 6 Lake (CI 15850), Red 7 Lake (CI 15850), Red 21 Lake (CI 45380), Red 27 Lake (CI 45410), Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140), Yellow 6 Lake (CI15985).

Indications and Usage (INDICATIONS AND USAGE)

To Use: Apply liberally as often as necessary.

Dosage & Administration (DOSAGE & ADMINISTRATION)

Apply to lips.

Otc Active Ingredient (OTC - ACTIVE INGREDIENT)

Active Ingredients: Petrolatum, 30.2% w/w, Padimate O, 8.0% w/w, Oxybenzone, 3.0% w/w.

Otc Keep Out of Reach of Children (OTC - KEEP OUT OF REACH OF CHILDREN)

Keep out of reach of children.

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

Advanced Ingredient Data

[{"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "ACTIB", "strengthNumerator": "1.117", "strengthDenominator": "3.7", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "PADIMATE O", "unii": "Z11006CMUZ", "classCode": "ACTIB", "strengthNumerator": "0.296", "strengthDenominator": "3.7", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "OXYBENZONE", "unii": "95OOS7VE0Y", "classCode": "ACTIB", "strengthNumerator": "0.111", "strengthDenominator": "3.7", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "CASTOR OIL", "unii": "D5340Y2I9G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MYRISTYL LACTATE", "unii": "1D822OC34X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CANDELILLA WAX", "unii": "WL0328HX19", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "YELLOW WAX", "unii": "2ZA36H0S2V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE WAX", "unii": "XOF597Q3KY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYLPARABEN", "unii": "3QPI1U3FV8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYLATED HYDROXYTOLUENE", "unii": "1P9D0Z171K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALPHA-TOCOPHEROL", "unii": "H4N855PNZ1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CORN OIL", "unii": "8470G57WFM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"WARNINGS": "Warning: If condition worsens or does not improve within 7 days, consult a physician.", "DESCRIPTION": "Moisturizes, softens and smooths lips. Provides antioxidant protection with vitamin E. SPF 15 protects against UV exposure. Provides a sheer wash of color in 6 translucent shades. Dermatologist, clinically and allergy tested.", "OTC - PURPOSE": "SPF 15 protects against UV exposure.", "OTC - WHEN USING": "Note condition.", "INACTIVE INGREDIENT": "Other Ingredients: Ozokerite, Ricinus Communis (Castor) Seed Oil, Glyceryl Rosinate, Cetyl Lactate, Lanolin Oil, Myristyl Lactate, Cetyl Acetate, Euphorbia Cerifera (Candelilla) Wax/Candelilla Cera/Cire De Candelilla, Copernicia Cerifera (Carnauba) Wax/Cer Carnauba/Cire De Carnauba, Beeswax/Cera Alba/Cire D'Abeille, Tocopherol, Acetylated Lanolin Alcohol, Methylstyrene/Vinyltoluene Copolymer, Microcrystalline Wax/Cera Microcristallina/Cire Microcristalline, BHT, Vegetable Oil/Olus/Huile Vegetale, Zea Mays (Corn) Oil, Citral Citronellol, Geraniol, Limonene, Linalool, Butylparaben, Propylparaben. May Contain: Blue 1 Lake (CI 42090), Iron Oxides (CI 77491, CI 77499, CI 77492), Red 6 Lake (CI 15850), Red 7 Lake (CI 15850), Red 21 Lake (CI 45380), Red 27 Lake (CI 45410), Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140), Yellow 6 Lake (CI15985).", "INDICATIONS AND USAGE": "To Use: Apply liberally as often as necessary.", "DOSAGE & ADMINISTRATION": "Apply to lips.", "OTC - ACTIVE INGREDIENT": "Active Ingredients: Petrolatum, 30.2% w/w, Padimate O, 8.0% w/w, Oxybenzone, 3.0% w/w.", "OTC - KEEP OUT OF REACH OF CHILDREN": "Keep out of reach of children."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information