MATTE MOISTURIZER SPF 15- octinoxate octisalate avobenzone cream

Matte Moisturizer SPF 15 by

Drug Labeling and Warnings

Matte Moisturizer SPF 15 by is a Otc medication manufactured, distributed, or labeled by Kamins Dermatologics Inc., Odan Laboratories Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients:

Avobenzone 2.5%

Octinoxate 7.5%

Octisalate 4%

PURPOSE

Purpose:

Sunscreen

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children.

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.

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

Directions

■ Apply liberally and evenly each morning to cleansed face and neck.

■ Children under 6 months of ask: ask a doctor

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

B. KAMINS

MATTE MOISTURIZER SPF15

50mL / 1.7 fl.oz

DIN 02274345

INGREDIENTS AND APPEARANCE

MATTE MOISTURIZER SPF 15 
octinoxate octisalate avobenzone cream

Product 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) , pack(63550-191)