GREEN TEA ANTIOXIDANT BROAD SPECTRUM SPF 30 PAPLUSPLUSPLUS- oxybenzone, octisalate, and avobenzone lotion

Green Tea Antioxidant Broad Spectrum SPF 30 PAplusplusplus by

Drug Labeling and Warnings

Green Tea Antioxidant Broad Spectrum SPF 30 PAplusplusplus by is a Otc medication manufactured, distributed, or labeled by H2O Plus LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Oxybenzone 6.0%	Sunscreen
Octisalate 5.0%	Sunscreen
Avobenzone 3.0%	Sunscreen

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

Warnings

• For external use only

• Do not use on damaged or broken skin

• Stop use and ask a doctor if rash occurs

When using this product

• Keep out of eyes, Rinse with water to remove.

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

Directions

• For Sunscreen use
• Apply liberally 15 minutes before sun exposure
• Use water resistance sunscreen if swimming or sweating
• Reapply at least every 2 hours
• Children under 6 months: Ask a doctor

Sun Protection Measures

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF value of 15 or higher and other sun protection measures including:

• Limit time in the sun especially from 10 am-2 pm
• Wear long-sleeved shirts, pants, and sunglasses

Inactive Ingredients

Aqua/Water/Eau, Ethylhexyl Isononanoate, Butylene Glycol, Glyceryl Stearate, C12-15 Alkyl Benzoate, Pentylene Glycol, Triisononanoin, Diethylhexyl 2,6-Naphthalate, Cera Alba/ Beeswax/Cire d'abeille, Sodium Dihydroxycetyl Phosphate, Polyglyceryl-3 Caprate, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Camellia Sinensis Leaf Extract, Faex/Yeast Extract/Extrait de levure, Fucus Vesiculosus Extract, Ilex Paraguariensis Leaf Extract, Panax Ginseng Root Extract, Tilia Cordata Wood Extract, Magnesium Ascorbyl Phosphate, Tocopherol, Biotin, Calcium Pantothenate, Carbomer, Citric Acid, Disodium EDTA, Glycerin, Glycogen, Hydrogenated Palm Glycerides, Hydrolyzed Wheat Protein, Lecithin, Mannitol, Maris Sal/Sea Salt/Sel Marin, Propylene Glycol, Thermus Thermophillus Ferment, Triethanolamine, Xanthan Gum, Chlorphenesin, Methylparaben, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate (090-00330-002)

Other information

• Protect the product in this container from excessive heat and direct sun

SPL UNCLASSIFIED SECTION

Distributed by:
H2O Plus, L.L.C. Chicago, IL 60607

PRINCIPAL DISPLAY PANEL - 38 mL Bottle Carton

h2o+®

marine DEFENSE

Anti-aging environmental
protection

GREEN TEA
ANTIOXIDANT LOTION
BROAD SPECTRUM
SPF 30 PA+++

Nourishes and protects
against free-radical
damage

38 mL / 1.3 U.S. Fl oz e

INGREDIENTS AND APPEARANCE

GREEN TEA ANTIOXIDANT BROAD SPECTRUM SPF 30 PAPLUSPLUSPLUS 
oxybenzone, octisalate, and avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65903-330
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	60 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)
Butylene Glycol (UNII: 3XUS85K0RA)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Pentylene Glycol (UNII: 50C1307PZG)
Triisononanoin (UNII: XF4K22WN6T)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
Yellow Wax (UNII: 2ZA36H0S2V)
Sodium Dihydroxycetyl Phosphate (UNII: YWI33EV595)
Tilia Cordata Wood (UNII: 674MYE89IE)
Horse Chestnut (UNII: 3C18L6RJAZ)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Yeast (UNII: 3NY3SM6B8U)
Fucus Vesiculosus (UNII: 535G2ABX9M)
Ilex Paraguariensis Leaf (UNII: 1Q953B4O4F)
Asian Ginseng (UNII: CUQ3A77YXI)
Magnesium Ascorbyl Phosphate (UNII: 0R822556M5)
Tocopherol (UNII: R0ZB2556P8)
Biotin (UNII: 6SO6U10H04)
Calcium Pantothenate (UNII: 568ET80C3D)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Edetate Disodium (UNII: 7FLD91C86K)
Glycerin (UNII: PDC6A3C0OX)
Glycogen (UNII: 309GSC92U1)
Hydrogenated Palm Glycerides (UNII: YCZ8EM144Q)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
Mannitol (UNII: 3OWL53L36A)
Sea Salt (UNII: 87GE52P74G)
Propylene Glycol (UNII: 6DC9Q167V3)
THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)
Trolamine (UNII: 9O3K93S3TK)
Xanthan Gum (UNII: TTV12P4NEE)
Chlorphenesin (UNII: I670DAL4SZ)
Methylparaben (UNII: A2I8C7HI9T)
Phenoxyethanol (UNII: HIE492ZZ3T)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Sodium Benzoate (UNII: OJ245FE5EU)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65903-330-01	1 in 1 CARTON
1		38 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2014

Labeler - H2O Plus LLC (807722947)