FACE OASIS HYDRATING FACE OASIS HYDRATING SPF 30- avobenzone,homosalate,octisalate,oxybenzone lotion

Face Oasis Hydrating by

Drug Labeling and Warnings

Face Oasis Hydrating by is a Otc medication manufactured, distributed, or labeled by H2O PLUS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone 3.0%
Homosalate 8.0%
Octisalate 4.0%
Oxybenzone 5.0%

Sunscreen
Sunscreen
Sunscreen
Sunscreen

Helps prevent sunburn
If used as directed with other sun protection measures
(see directions) decreases the risk of skin cancers and early skin aging

For external use only Do not use on damaged or broken skin
Stop use and ask a doctor if rash occurs

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

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

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

Aqua/Water/Eau, Ascorbyl Tetraisopalmitate, Blue 1 (CI 42090), Butylene
Glycol, C12-15 Alkyl Benzoate, C12-20 Alkyl Glucoside, C14-22 Alcohols,
Caprylic/Capric Triglyceride, Carbomer, Crithmum Maritimum Extract,
Cyclopentasiloxane, Dimethicone, DNA, Ext. Violet 2 (CI 60730), Glycerin,
Glyceryl Stearate, Leuconostoc/Radish Root Ferment Filtrate, Linalool,
Magnesium Ascorbyl Phosphate, Methylisothiazolinone,
Parfum/Fragrance, Phenoxyethanol, Phospholipids, Silica, Tocopherol,
Triethanolamine, Trisiloxane, Ulva Lactuca Extract, Undaria Pinnatifida
Extract, Xanthan Gum

PRINCIPAL DISPLAY PANEL

Image of Carton Label fa270.jpg

INGREDIENTS AND APPEARANCE

FACE OASIS HYDRATING   FACE OASIS HYDRATING SPF 30
avobenzone,homosalate,octisalate,oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65903-270
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	3 mL  in 100 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	8 mL  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	4 mL  in 100 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
CRITHMUM MARITIMUM (UNII: J7IHY79BKY)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
HERRING SPERM DNA (UNII: 51FI676N6F)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TOCOPHEROL (UNII: R0ZB2556P8)
TRIETHANOLAMINE HYDROCHLORIDE (UNII: R297UJ9QDY)
TRISILOXANE (UNII: 9G1ZW13R0G)
ULVA LACTUCA (UNII: PHR3P25W6Y)
UNDARIA PINNATIFIDA (UNII: ICV1OK7M1S)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65903-270-01	1 in 1 CARTON
1		38 mL in 1 BOTTLE, DISPENSING

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/01/2012

Labeler - H2O PLUS (807722947)