Label: MATTE MOISTURIZER SPF 15- octinoxate octisalate avobenzone cream
- NDC Code(s): 63550-191-03
- Packager: Kamins Dermatologics Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 December 1, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
A light, comforting, daytime moisturizer, free of oil and fragrance to help delicately hydrate and protect oily skin. Contains our exclusive Bio-Maple compound, a complex humectant to help condition and hydrate skin. Also contains SPF 15 sunscreens to help protect skin from harmful UVA/UVB sunrays. May be used alone or as a base for oil-free makeup.
Uses
■ Helps prevent sunburn.■ Higher SPF gives more sunburn protection.
■ Provides high protection against sunburn.
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WARNINGS
Warnings
For external use only.
When using this product, keep out of eyes. If contact occurs, rinse abundantly with water to remove
Stop use and ask a doctor if rash or irritation develops and lasts.
If swallowed, seek medical assistance or contact a Poison Control Center immediately.Other information
Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive ingredients:
alcohol denat., ethyl macadamiate, tocopherol, malic acid, diethylhexyl 2,6-naphthalate, PPG-5-ceteth-20, acrylates/octylacrylamide copolymer, ethylene brassylate, lauryl PCA, tocopheryl acetate, acer saccharum (maple isolate), punica granatum (pomegranate) extract, propylene glycol, water, euterpe oleracea (acai) oil, retinyl palmitate, magnesium ascorbyl phosphate.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MATTE MOISTURIZER SPF 15
octinoxate octisalate avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63550-191 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 40 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 25 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ACER SACCHARUM SAP (UNII: 75UOH57984) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) OCTOCRYLENE (UNII: 5A68WGF6WM) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CETYL ALCOHOL (UNII: 936JST6JCN) CETEARETH-12 (UNII: 7V4MR24V5P) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SORBIC ACID (UNII: X045WJ989B) QUADROSILAN (UNII: C5KT601WPM) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM HYDROXIDE (UNII: 55X04QC32I) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63550-191-03 50 mL in 1 BOX; Type 0: Not a Combination Product 10/01/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 10/01/2010 Labeler - Kamins Dermatologics Inc. (254050784) Registrant - Kamins Dermatologics Inc. (254050784) Establishment Name Address ID/FEI Business Operations Odan Laboratories Ltd 208585604 manufacture(63550-191)
