H2O BEAUTY AQUADEFENSE PROTECTIVE MATCHA SPF 40- avobenzone, homosalate, octisalate, octocrylene lotion

H2O Beauty AQUADEFENSE by

Drug Labeling and Warnings

H2O Beauty AQUADEFENSE by is a Otc medication manufactured, distributed, or labeled by Bentley Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug FactsActive Ingredients

Avobenzone 3.0%
Homosalate 8.0%
Octisalate 5.0%
Octocrylene 6.0%

Purpose

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 caused by the sun

Warnings

• For external use only
• Do not use on damaged or broken skin
• When using this product avoid contact with eyes. If contact occurs, flush thoroughly with water
• 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 immediately.

Directions

For sunscreen use:

• Apply liberally 15 minutes before sun exposure
• Reapply at least every two hours
• Use a water resistant sunscreen if swimming or sweating
• For 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 a Broad Spectrum SPF 15 or higher and other sun protection measures including:

• Limit time in the sun, especially from 10a.m. - 2p.m.
• Wear long-sleeve shirts, pants, hats and sunglasses.

Other Information

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

Inactive Ingredients

Water/Aqua/Eau, Butyloctyl Salicylate, Dimethicone, Butylene Glycol, Aluminum Starch Octenylsuccinate, Styrene/Acrylates Copolymer, Methyl Methacrylate Crosspolymer, Glycerin, Octyldodecyl Neopentanoate, PEG-8  Stearate, Glyceryl Stearate, Citrullus Lanatus (Watermelon) Fruit Extract, Lens Esculanta (Lentil) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Oryza Sativa (Rice) Bran Extract, Camellia Sinensis Leaf Extract, Sodium Hyaluronate, Hydrolyzed Algin, Sodium Lactate, Xanthan Gum, VP/Eicosene Copolymer, PEG-100 stearate, Cetearyl Alcohol, Caprylyl Glycol, Sorbitan Oleate, PEG-8 Laurate, Hexylene Glycol, Disodium EDTA, Citric Acid, Sodium PCA, Sodium Benzoate, Potassium Sorbate, Phenowyethanol, Fragrance/Parfum, Limonene, Buthyphenyl Methylpropional, Linalool, Citral, Citronellol, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde (090-50103-000)

Questions ? Comments ?

Call 1-800-242-2284, M-F 9am - 5pm PST

H2O+™ BEAUTY AQUADEFENSEPROTECTIVE MATCHA MOISTURIZER SPF 40 product label

H2O+™ BEAUTY AQUADEFENSE
PROTECTIVE MATCHA MOISTURIZER SPF 40

SUN PROTECTION + ENVIROMENTAL
STRESSOR SHIELD

50 mL 1.7 U.S. FL oz

AQUADEFENSE PROTECTIVE MATCHA MOISTURIZER SPF 40

SHOW ME THE SUN l Our Protective Matcha Moisturizer SPF 40 packs a punch of broad spectrum coverage without any leftover white residue. Featuring Matcha Green Tea and Rice Bran extracts, it protects against the stress of sun exposure and moisture loss and therefore helps ward off the appearance of wrinkles. Its ultra-lightweight texture and fast absorbing finish will knock-your-flops off.

USES l Helps prevent sunburn. If used as directed with other sun measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

DIRECTIONS l For sunscreen use: Shake well. Apply liberally 15 minutes before sun exposure. Reapply at least every two hours. For children under 6 months, ask a doctor.

H2O+™

Distributed by: H2o Plus, LLC

San Francisco, CA. 94104
www.H2OPLUS.COM

©2016 MADE IN USA

083-50103-002  50103

INGREDIENTS AND APPEARANCE

H2O BEAUTY AQUADEFENSE  PROTECTIVE MATCHA SPF 40
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54111-132
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	4 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: 657L0NC5MT)
GLYCERIN (UNII: PDC6A3C0OX)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PEG-8 STEARATE (UNII: 2P9L47VI5E)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
WATERMELON (UNII: 231473QB6R)
LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)
APPLE (UNII: B423VGH5S9)
RICE BRAN (UNII: R60QEP13IC)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
SODIUM LACTATE (UNII: TU7HW0W0QT)
XANTHAN GUM (UNII: TTV12P4NEE)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
PEG-100 STEARATE (UNII: YD01N1999R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
PEG-8 LAURATE (UNII: 762O8IWA10)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CITRAL (UNII: T7EU0O9VPP)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54111-132-50	50 mL in 1 TUBE; Type 0: Not a Combination Product	12/06/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/06/2016

Labeler - Bentley Laboratories, LLC (068351753)