Green Defense Broad Spectrum Spf 30

Green Defense Broad Spectrum Spf 30
SPL v4
SPL
SPL Set ID adf0f50f-6357-bc1f-e053-2a95a90ad997
Route
TOPICAL
Published
Effective Date 2020-08-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (24 mg) Zinc Cation (58.2 mg)
Inactive Ingredients
Water Ethyl Macadamiate Cyclomethicone 5 Ethylhexyl Palmitate Alkyl (c12-15) Benzoate Propanediol Polysorbate 80 Glyceryl Monostearate Peg-100 Stearate Cetyl Alcohol Polyglyceryl-6 Isostearate Dimethicone Echinacea Purpurea Root Aronia Melanocarpa Fruit Juice Tagetes Erecta Flower Sunflower Oil Safflower Oil Malic Acid Tocopherol Myristic Acid Glycerin Hydrogenated Soybean Lecithin Panthenol Stearic Acid Microcrystalline Cellulose Aluminum Oxide Behenic Acid Stearyl Alcohol Caprylyl Trisiloxane Cyclomethicone 6 Isohexadecane Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone 1,2-hexanediol Docosanol Triethoxycaprylylsilane Polyhydroxystearic Acid (2300 Mw) Sodium Acrylate/sodium Acryloyldimethyltaurate Copolymer (4000000 Mw) Carboxymethylcellulose Sodium, Unspecified Sorbitan Monooleate Butylene Glycol Phenoxyethanol Caprylyl Glycol Ethylhexylglycerin Sodium Benzoate Potassium Sorbate Sodium Citrate Citric Acid Monohydrate Hexasodium Phytate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-05-31

Description

Titanium Dioxide 2.40% Zinc Oxide 5.82%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 2.40% Zinc Oxide 5.82%

Uses
  • helps prevent sunburn
  • if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions
Warnings

For external use only.

Directions
  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  •  Spending time in the sun increase your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Sun Protection Measure.
  • Limit time in the sun, especially from 10 a.m.-2-p.m.
  • Wear long sleeved shirts, pants, hats and sunglasses
  • Children under 6 months: Ask a doctor
Do Not Use

on damaged or broken skin.

Drug Facts

Other Information
  • Protect the product in this container from excessive heat and direct sunlight.
  • You may report a serious adverse event from use of this product to: 1-844-432-7622 Farmacy Beauty LLC. 1111 MacArthur Blvd. Mahwah NJ 07430
Package Labeling:

Active Ingredients

Titanium Dioxide 2.40%

Zinc Oxide 5.82%

Inactive Ingredients

Water (Aqua), Ethyl Macadamiate, Cyclopentasiloxane, Ethylhexyl Palmitate, C12-15 Alkyl Benzoate, Propanediol, Polysorbate 80, Glyceryl Stearate, PEG-100 Stearate, Cetyl Alcohol, Polyglyceryl-6 Isostearate, Dimethicone, Echinacea Purpurea Root Extract, Aronia Melanocarpa Fruit Extract, Hydrolyzed Verbascum Thapsus Flower, Tagetes Erecta Flower Extract, Alteromonas Ferment Extract, Helianthus Annuus (Sunflower) Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Malic Acid, Tocopherol, Myristic Acid, Glycerin, Hydrogenated Lecithin, Panthenol, Stearic Acid, Microcrystalline Cellulose, Alumina, Behenic Acid, stearyl Alcohol, Carprylyl Methicone, Cyclohexasiloxane, Isohexadecane, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, 1,2-Hexanediol, Beheny Alcohol, Triethoxycaprylylsilane, Polyhydroxystearic Acid, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Cellulose Gum, sorbitan Oleate, Butylene Glycol, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Sodium Benzoate, Potassium Sorbate, Sodium Citrate, Citric Acid, Sodium Phytate

When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor

if rash occurs.

Keep Out of Reach of Children.

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


Structured Label Content

Uses
  • helps prevent sunburn
  • if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions
Purpose

Sunscreen

Warnings

For external use only.

Directions
  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  •  Spending time in the sun increase your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Sun Protection Measure.
  • Limit time in the sun, especially from 10 a.m.-2-p.m.
  • Wear long sleeved shirts, pants, hats and sunglasses
  • Children under 6 months: Ask a doctor
Do Not Use (Do not use)

on damaged or broken skin.

Drug Facts

Other Information (Other information)
  • Protect the product in this container from excessive heat and direct sunlight.
  • You may report a serious adverse event from use of this product to: 1-844-432-7622 Farmacy Beauty LLC. 1111 MacArthur Blvd. Mahwah NJ 07430
Package Labeling:

Active Ingredients (ACTIVE INGREDIENTS)

Titanium Dioxide 2.40%

Zinc Oxide 5.82%

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Ethyl Macadamiate, Cyclopentasiloxane, Ethylhexyl Palmitate, C12-15 Alkyl Benzoate, Propanediol, Polysorbate 80, Glyceryl Stearate, PEG-100 Stearate, Cetyl Alcohol, Polyglyceryl-6 Isostearate, Dimethicone, Echinacea Purpurea Root Extract, Aronia Melanocarpa Fruit Extract, Hydrolyzed Verbascum Thapsus Flower, Tagetes Erecta Flower Extract, Alteromonas Ferment Extract, Helianthus Annuus (Sunflower) Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Malic Acid, Tocopherol, Myristic Acid, Glycerin, Hydrogenated Lecithin, Panthenol, Stearic Acid, Microcrystalline Cellulose, Alumina, Behenic Acid, stearyl Alcohol, Carprylyl Methicone, Cyclohexasiloxane, Isohexadecane, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, 1,2-Hexanediol, Beheny Alcohol, Triethoxycaprylylsilane, Polyhydroxystearic Acid, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Cellulose Gum, sorbitan Oleate, Butylene Glycol, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Sodium Benzoate, Potassium Sorbate, Sodium Citrate, Citric Acid, Sodium Phytate

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs.

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

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)