SOOTHING DAY SPF 15- avobenzone octinoxate oxybenzone cream 
Kamins Dermatologics Inc.

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.

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Soothing Day Cream SPF 15 CONSUMER LABELING

Active ingredients:
Avobenzone 2%

Octinoxate 7%

Octibenzone 5%

Purpose:

Sunscreen

Keep out of the reach of children.

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
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 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.

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

B. KAMINS

Soothing Day Cream SPF15

50mL / 1.7 fl.oz

DIN 02275791 Soothing Day front panel image

SOOTHING DAY SPF 15 
avobenzone octinoxate oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63550-192
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE70 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
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)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63550-192-0750 mL in 1 BOX; Type 0: Not a Combination Product10/01/2010
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/01/2010
Labeler - Kamins Dermatologics Inc. (254050784)
Registrant - Kamins Dermatologics Inc. (254050784)
Establishment
NameAddressID/FEIBusiness Operations
Odan Laboratories Ltd208585604manufacture(63550-192)

Revised: 12/2022
Document Id: eecb2903-8256-a4e6-e053-2995a90aba16
Set id: 72e3bec8-e6a1-4c92-bb19-eaf0fe08167c
Version: 7
Effective Time: 20221201
 
Kamins Dermatologics Inc.