Drug Facts

ACTIVE INGREDIENTS

Titanium Dioxide 2.40%

Zinc Oxide 5.82%

Purpose

Sunscreen

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.

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 of reach of children.

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

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

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

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

Package Labeling:

Bottle Bottle2

GREEN DEFENSE BROAD SPECTRUM SPF 30
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72830-261
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	24 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	58.2 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PROPANEDIOL (UNII: 5965N8W85T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
CETYL ALCOHOL (UNII: 936JST6JCN)
POLYGLYCERYL-6 ISOSTEARATE (UNII: 5VKGO1O03G)
DIMETHICONE (UNII: 92RU3N3Y1O)
ECHINACEA PURPUREA ROOT (UNII: OS64WTR4KU)
ARONIA MELANOCARPA FRUIT JUICE (UNII: D2EVP827PJ)
TAGETES ERECTA FLOWER (UNII: UH5X33P33E)
SUNFLOWER OIL (UNII: 3W1JG795YI)
SAFFLOWER OIL (UNII: 65UEH262IS)
MALIC ACID (UNII: 817L1N4CKP)
TOCOPHEROL (UNII: R0ZB2556P8)
MYRISTIC ACID (UNII: 0I3V7S25AW)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
PANTHENOL (UNII: WV9CM0O67Z)
STEARIC ACID (UNII: 4ELV7Z65AP)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
ALUMINUM OXIDE (UNII: LMI26O6933)
BEHENIC ACID (UNII: H390488X0A)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ISOHEXADECANE (UNII: 918X1OUF1E)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
DOCOSANOL (UNII: 9G1OE216XY)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HEXASODIUM PHYTATE (UNII: ZBX50UG81V)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72830-261-50	50 mL in 1 TUBE; Type 0: Not a Combination Product	05/31/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	05/31/2020

Labeler - Farmacy (081343430)

Green Defense Broad Spectrum SPF 30