Pharmagel - Derma Brite (67879-308)

Pharmagel - Derma Brite (67879-308)
SPL v6
SPL
SPL Set ID fe10912e-00e3-406c-a80c-d9c991dc9f8b
Route
TOPICAL
Published
Effective Date 2016-06-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7.5 g) Octisalate (5 g) Oxybenzone (3 g)
Inactive Ingredients
Water Tangerine Peel Ethylhexyl Palmitate Propylene Glycol Glyceryl Monostearate Peg-100 Stearate Cetostearyl Alcohol Dimethicone Palmitic Acid Phenoxyethanol Stearic Acid Myristyl Myristate Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Caprylyl Glycol Hydroxyethyl Cellulose (100 Mpa.s At 2%) Trolamine Glycerin Ethylhexylglycerin Allantoin Hexylene Glycol Myristyl Laurate Panthenol Edetate Sodium Glycolic Acid Butylene Glycol Morus Alba Leaf Myristic Acid Kojic Acid Magnesium Ascorbyl Phosphate Niacin Phyllanthus Emblica Fruit Undecylenoyl Phenylalanine Glycyrrhiza Glabra Arachidic Acid Green Tea Leaf Butylated Hydroxytoluene Potassium Sorbate Cyperus Rotundus Root Limonene, (+)- Sodium Citrate Linalool, (+)- Anhydrous Citric Acid .beta.-citronellol, (+/-)- Sodium Benzoate Lactic Acid Fd&c Yellow No. 6 Biotin Fd&c Red No. 40 Undecylenic Acid Chlorphenesin Benzoic Acid Sorbic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-06-18

Description

Octinoxate 7.5% Octisalate 5.0% Oxybenzone 3.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octinoxate 7.5% Octisalate 5.0% Oxybenzone 3.0%

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
Section 50565-1

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

Section 51945-4

Warnings

For external use only.

Do not use on damaged or broken skin.

When using product keep out of eyes. Rinse with warm water to remove.

Stop use and ask doctor if rash occurs

Directions

• apply liberally 15 minutes before sun exposure

• reapply:

• after 40 minutes of swimming or sweating.

• immediately after towel drying

• at least every 2 hours

• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 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-sleeve shirts, pants, hats and sunglasses

• children under 6 months: Ask a doctor

Active Ingredients

Octinoxate 7.5%

Octisalate 5.0%

Oxybenzone 3.0%

Inactive Ingredients:

water (aqua, eau), citrus unshiu peel extract, ethylhexyl palmitate, propylene glycol, glyceryl stearate, peg-100 stearate, cetearyl alcohol, dimethicone, palmitic acid, phenoxyethanol, stearic acid, myristyl myristate, acrylates/c10-30 alkyl acrylate crosspolymer, caprylyl glycol, hydroxyethylcellulose, triethanolamine, glycerin, ethylhexylglycerin, allantoin, hexylene glycol, myristyl laurate, panthenol, tetrasodium edta, fragrance (parfum), glycolic acid, butylene glycol, morus alba leaf extract, myristic acid, kojic acid, magnesium ascorbyl phosphate, niacin, phyllanthus emblica fruit exract, undecylenoyl phenylalanine, glycyrrhiza glabra (licorice) root extract, arachidic acid, camellia sinensis (green tea) leaf extract, bht, potassium sorbate, cyperus rotundus root extract, limonene, sodium citrate, linalool, citric acid, citronellol, sodium benzoate, lactic acid, yellow 6 (ci 15985), biotin, red 40 (ci 16035), undecylenic acid, chlorphenesin, benzoic acid, sorbic acid


Structured Label Content

Uses (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
Section 50565-1 (50565-1)

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

Section 51945-4 (51945-4)

Purpose (PURPOSE)

Sunscreen

Warnings (WARNINGS)

For external use only.

Do not use on damaged or broken skin.

When using product keep out of eyes. Rinse with warm water to remove.

Stop use and ask doctor if rash occurs

Directions (DIRECTIONS)

• apply liberally 15 minutes before sun exposure

• reapply:

• after 40 minutes of swimming or sweating.

• immediately after towel drying

• at least every 2 hours

• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 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-sleeve shirts, pants, hats and sunglasses

• children under 6 months: Ask a doctor

Active Ingredients (ACTIVE INGREDIENTS)

Octinoxate 7.5%

Octisalate 5.0%

Oxybenzone 3.0%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

water (aqua, eau), citrus unshiu peel extract, ethylhexyl palmitate, propylene glycol, glyceryl stearate, peg-100 stearate, cetearyl alcohol, dimethicone, palmitic acid, phenoxyethanol, stearic acid, myristyl myristate, acrylates/c10-30 alkyl acrylate crosspolymer, caprylyl glycol, hydroxyethylcellulose, triethanolamine, glycerin, ethylhexylglycerin, allantoin, hexylene glycol, myristyl laurate, panthenol, tetrasodium edta, fragrance (parfum), glycolic acid, butylene glycol, morus alba leaf extract, myristic acid, kojic acid, magnesium ascorbyl phosphate, niacin, phyllanthus emblica fruit exract, undecylenoyl phenylalanine, glycyrrhiza glabra (licorice) root extract, arachidic acid, camellia sinensis (green tea) leaf extract, bht, potassium sorbate, cyperus rotundus root extract, limonene, sodium citrate, linalool, citric acid, citronellol, sodium benzoate, lactic acid, yellow 6 (ci 15985), biotin, red 40 (ci 16035), undecylenic acid, chlorphenesin, benzoic acid, sorbic acid


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)