WATERBRIGHT RADIATING- avobenzone, octinoxate, octisalate, octocrylene, oxybenzone cream

WATERBRIGHT RADIATING by

Drug Labeling and Warnings

WATERBRIGHT RADIATING 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%

Octinoxare 7.5%

Octisalate 5.0%

Octocrylene 9.0%

Oxybenzone 5.0%

Purpose

Sunscreen

Keep out of reach of children

• Keep out of reach of children.

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

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

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 10 a.m. - 2 p.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, C12-15 Alkyl Benzoate, Glycerin, Propylene Glycol, Cyclopentasiloxane, Trisiloxane, Dimethicone, Glyceryl Stearate, Vits Vinifera (Grape) Fruit Extract, Palmaria, Palmata Extract, Leucojum Aestivum Bulb Extract, Citrus Paradis (Grapefruit) Peel Extract, Scutellaria Balcalensis Root Extract, Spirulina Maxima Extract, Ascophyllum Nodosum Extract, Morus Bombycic Root Extract, Laminaria Digitala Extract, Saxifraga Sarmentosa Extract, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Ascorbic Acid, Ascorbyl Glucoside, Sodium Sulfite, Sodium Metabisulfite, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, PEG-100 Stearate, Isohexadecane, Cetearyl Alcohol, Cetearyl Glucoside, Xanthan Gum, Ethylhexylglycerin, Polysorbate 60, Sorbitan Isostearate, Butylene Glycol, Sodium Hydroxide, Disodium EDTA, Potassium Sorbate, Potassium Benzoate, Citric Acid, Sodium Benzoate, Phenoxyethanol, Parfum/Fragrance, Citronellol, Butylphenyl Methylpropional, Alpha-Isomethyl Ionone, Limonene, Hexyl Cinnamal, Linalool, Benzyl Salicylate (090-50149-001)

Questions? Comments?

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

H2O BEAUTY product label

H2O+ ™

BEAUTY

WATERBRIGHT
RADIATING MOISTURIZER
SPF 30

VITAMIN C + SUN PROTECTION

50 mL 1.7 U.S. Fl oz

WATER

We plus it up with energy, confidence, and advanced technology. The result is positively smart.

WATERBRIGHT RADIATING MOISTURIZER SPF 30

 READY. SET. GLOW!

Dial up your skin's Wow Factor with the broad spectrum coverage of our Radiating Moisturizer SPF 30. This powerhouse formula is infused with Vitamin C known to combat dull, uneven skin tone. This fast absorbing cream contains Pomelo and Snowflake Flower extracts and an essential concentration of SPF. Protect yourself from the sun's harmful rays, sealing in all that newly acquired radiance. You glow, girl.

HOW TO USE
Massage on to face, neck, and chest every morning after cleansing and toning. Reapply every two hours. For bestesults, apply over your favorite H2O+ Beauty serum.

Distributed by: H2O Plus, LLC

San Francisco, CA 94104

WWW.H2OPLUS.COM

2016 MADE IN THE USA

400-5014-001  50149

INGREDIENTS AND APPEARANCE

WATERBRIGHT RADIATING 
avobenzone, octinoxate, octisalate, octocrylene, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54111-129
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
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.75 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4.5 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2.5 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TRISILOXANE (UNII: 9G1ZW13R0G)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
WINE GRAPE (UNII: 3GOV20705G)
DULSE (UNII: 7832HOY4ZQ)
LEUCOJUM AESTIVUM BULB (UNII: 190M641M70)
GRAPEFRUIT PEEL (UNII: 3582N05Q44)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
SPIRULINA MAXIMA (UNII: 9K7IG15M0Q)
ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ)
MORUS AUSTRALIS ROOT (UNII: 1VL55O45RF)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
SODIUM SULFITE (UNII: VTK01UQK3G)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
PEG-100 STEARATE (UNII: YD01N1999R)
ISOHEXADECANE (UNII: 918X1OUF1E)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
XANTHAN GUM (UNII: TTV12P4NEE)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POTASSIUM BENZOATE (UNII: 763YQN2K7K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54111-129-50	50 mL in 1 TUBE; Type 0: Not a Combination Product	06/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/01/2016

Labeler - Bentley Laboratories, LLC (068351753)