NDC | 65903-270-01 |
Set ID | 2bfe13c3-ddf0-4f05-ad40-751b1b808bf3 |
Category | HUMAN OTC DRUG LABEL |
Packager | H2O PLUS |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
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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)