Lipcōtz

Lipcōtz
SPL v1
SPL
SPL Set ID 0d0bd849-3f96-4d7a-9ca9-7cf93f4e001b
Route
TOPICAL
Published
Effective Date 2010-09-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (40 mg) Zinc Oxide (55 mg)
Inactive Ingredients
Aluminum Oxide Aluminum Hydroxide Aluminum Stearate Ascorbic Acid Ascorbyl Palmitate C12-15 Alkyl Benzoate Ceresin Cetearyl Isononanoate Anhydrous Citric Acid Propylene Glycol Dicaprylate/dicaprate Ethylhexyl Palmitate Kiwi Fruit Lime (citrus) Sunflower Oil Hexyldecanol Hexyldecyl Laurate Ferric Oxide Red Lecithin, Soybean Polyethylene Glycol 400 Stearic Acid Alpha-tocopherol .alpha.-tocopherol Acetate, D- Ginger Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2005-04-01

Description

Drug Facts

Purpose

Sunscreen Sunscreen


Medication Information

Purpose

Sunscreen

Sunscreen

Description

Drug Facts

Uses:

Helps prevent sunburn; higher SPF gives more sunburn protection for skin that sunburns easily

Section 42229-5

Drug Facts

Warnings:

For External Use Only. Stop use and consult a physician if rash or irritation develops. Avoid contact with eyes.

Directions:

Apply generously to lips prior to sun exposure. Reapply often and after water activity, excessive perspiration or towel drying. Children under 6 years old, consult a physician.

Active Ingredients

Titanium Dioxide 4.0%

Zinc Oxide 5.5%

Inactive Ingredients:

Alumina, Aluminum Hydroxide, Aluminum Stearate, Ascorbic Acid, Ascorbyl Palmitate, C12-15 Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Dipropylene Glycol Dicaprylate-Caprate, Ethylhexyl Palmitate, Flavor, Helianthus Annus (Sunflower) Seed Wax, Hexyldecanol, Hexyldecyl Laurate, Iron Oxides, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Diisostearate, Polyhydroxy Stearic Acid, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Offinale (Ginger) Root Oil

Keep Out of Reach of Children:

If swallowed, get medical help or contact a Poison Control Center.

Principal Display Panel – Carton Label

NDC 58892-125-87

SPF 45

LIPCŌTZ

Contains Only Titanium & Zinc™

SPF 45

Contains Only Titanium & Zinc™

Ultra High Sun Protection no chemical sunscreen filters

Net Wt. .14 Oz./ 4.5 g

For Information Call:

800-332-5536

Manufactured for: Fallene, Ltd

West Norriton, PA


Structured Label Content

Uses:

Helps prevent sunburn; higher SPF gives more sunburn protection for skin that sunburns easily

Section 42229-5 (42229-5)

Drug Facts

Purpose

Sunscreen

Sunscreen

Warnings:

For External Use Only. Stop use and consult a physician if rash or irritation develops. Avoid contact with eyes.

Directions:

Apply generously to lips prior to sun exposure. Reapply often and after water activity, excessive perspiration or towel drying. Children under 6 years old, consult a physician.

Active Ingredients

Titanium Dioxide 4.0%

Zinc Oxide 5.5%

Inactive Ingredients:

Alumina, Aluminum Hydroxide, Aluminum Stearate, Ascorbic Acid, Ascorbyl Palmitate, C12-15 Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Dipropylene Glycol Dicaprylate-Caprate, Ethylhexyl Palmitate, Flavor, Helianthus Annus (Sunflower) Seed Wax, Hexyldecanol, Hexyldecyl Laurate, Iron Oxides, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Diisostearate, Polyhydroxy Stearic Acid, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Offinale (Ginger) Root Oil

Keep Out of Reach of Children: (Keep out of reach of children:)

If swallowed, get medical help or contact a Poison Control Center.

Principal Display Panel – Carton Label

NDC 58892-125-87

SPF 45

LIPCŌTZ

Contains Only Titanium & Zinc™

SPF 45

Contains Only Titanium & Zinc™

Ultra High Sun Protection no chemical sunscreen filters

Net Wt. .14 Oz./ 4.5 g

For Information Call:

800-332-5536

Manufactured for: Fallene, Ltd

West Norriton, PA


Advanced Ingredient Data


Raw Label Data

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