H2O Beauty AQUADEFENSE PROTECTIVE MATCHA SPF 40: Package Insert and Label Information

H2O BEAUTY AQUADEFENSE PROTECTIVE MATCHA SPF 40- avobenzone, homosalate, octisalate and octocrylene lotion
Bentley Laboratories, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts Active 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 AQUADEFENSE PROTECTIVE 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

Bentley H2O Aquadefense 132
(click image for full-size original)
Bentley H2O Aquadefense 132 1
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 1.5 g in 50 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE 4 g in 50 mL
OCTISALATE (OCTISALATE) OCTISALATE 2.5 g in 50 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 3 g in 50 mL
Inactive Ingredients
Ingredient Name Strength
WATER
BUTYLOCTYL SALICYLATE
DIMETHICONE
BUTYLENE GLYCOL
ALUMINUM STARCH OCTENYLSUCCINATE
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER
GLYCERIN
OCTYLDODECYL NEOPENTANOATE
PEG-8 STEARATE
GLYCERYL STEARATE CITRATE
WATERMELON
LENS CULINARIS FRUIT
APPLE
RICE BRAN
GREEN TEA LEAF
HYALURONATE SODIUM
SODIUM ALGINATE
SODIUM LACTATE
XANTHAN GUM
VINYLPYRROLIDONE/EICOSENE COPOLYMER
PEG-100 STEARATE
CETOSTEARYL ALCOHOL
CAPRYLYL GLYCOL
SORBITAN MONOOLEATE
PEG-8 LAURATE
HEXYLENE GLYCOL
EDETATE DISODIUM ANHYDROUS
CITRIC ACID MONOHYDRATE
SODIUM PYRROLIDONE CARBOXYLATE
SODIUM BENZOATE
POTASSIUM SORBATE
PHENOXYETHANOL
LIMONENE, (+)-
BUTYLPHENYL METHYLPROPIONAL
LINALOOL, (+/-)-
CITRAL
.BETA.-CITRONELLOL, (R)-
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54111-132-50 50 mL in 1 TUBE None
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)

Revised: 12/2018 Bentley Laboratories, LLC

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