Drug Facts

FACE OASIS HYDRATING FACE OASIS HYDRATING SPF 30- avobenzone,homosalate,octisalate,oxybenzone lotion
H2O PLUS

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

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

Image of Carton Label fa270.jpg

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - H2O PLUS (807722947)