Label: FACE OASIS HYDRATING FACE OASIS HYDRATING SPF 30- avobenzone,homosalate,octisalate,oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 65903-270-01 - Packager: H2O PLUS
- Category: HUMAN OTC DRUG LABEL
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 Label Information
Updated September 27, 2011
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Avobenzone 3.0%
Homosalate 8.0%
Octisalate 4.0%
Oxybenzone 5.0%
Helps prevent sunburn
If used as directed with other sun protection measures
(see directions) decreases the risk of skin cancers and early skin agingFor external use only • Do not use on damaged or broken skin
Keep out of eyes, Rinse with water to remove. Keep out of reach of children.
• Stop use and ask a doctor if rash occurs
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 doctorAqua/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
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INGREDIENTS AND APPEARANCE
FACE OASIS HYDRATING FACE OASIS HYDRATING SPF 30
avobenzone,homosalate,octisalate,oxybenzone lotionProduct 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)
