SOOTHING DAY SPF 15- avobenzone octinoxate oxybenzone cream

Soothing Day SPF 15 by

Drug Labeling and Warnings

Soothing Day 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%

Octinoxate 7%

Octibenzone 5%

PURPOSE

Purpose:

Sunscreen

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children.

INDICATIONS & USAGE

A gentle cosmetic emollient preparation that helps moisturize dry skin conditions associated with rosacea and related couperose skin complexions.  Free of fragrance, this formula contains antioxidants and soothing Bio-Maple compound to help moisturize and relieve inflammation.  Also helps protect skin from UVA and UVB sun rays, which are known to be harmful to rosacea type skins.  This high-performance, anti-aging daily moisturizer is a perfect primer for makeup.

Uses

■ Helps prevent sunburn.

■ Higher SPF gives more sunburn protection.

■ Provides high protection against sunburn.

WARNINGS

Warnings
For external use only.
Avoid contact with eyes when using this product. 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.

INACTIVE INGREDIENT

Inactive ingredients:

water, cetyl alcohol, PEG-100 stearate, glyceryl stearate, soluble collagen, glycerin, squalane, acer saccharum (maple isolate/isolat d’érable), PEG-16 soy sterol, ceteareth-12, diethylhexyl 2,6-naphthalate, cyclotetrasiloxane, cyclopentasiloxane, PEG/PPG-18/18 dimethicone, xanthan gum, tocopheryl acetate, retinyl palmitate, sodium hydroxide, carbomer, phenoxyethanol, chlorphenesin.

DOSAGE & ADMINISTRATION

Directions

■ Apply liberally and evenly each morning to cleansed face and neck, before sun exposure ans as needed

■ Children under 6 months of ask: ask a doctor

PRINCIPAL DISPLAY PANEL

B. KAMINS

Soothing Day Cream SPF15

50mL / 1.7 fl.oz

DIN 02275791

INGREDIENTS AND APPEARANCE

SOOTHING DAY SPF 15 
avobenzone octinoxate oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63550-192
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	70 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
POLYOXYL 100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERIN (UNII: PDC6A3C0OX)
SQUALANE (UNII: GW89575KF9)
ACER SACCHARUM SAP (UNII: 75UOH57984)
CETETH-16 (UNII: 94826GMB5B)
CETEARETH-12 (UNII: 7V4MR24V5P)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
QUADROSILAN (UNII: C5KT601WPM)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
XANTHAN GUM (UNII: TTV12P4NEE)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63550-192-07	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(63550-192) , pack(63550-192)