Soothing Day SPF 15

Dosage form: cream
Ingredients: AVOBENZONE 20mg in 1mL, OCTINOXATE 70mg in 1mL, OXYBENZONE 50mg in 1mL
Labeler: Kamins Dermatologics Inc.
NDC Code: 63550-192

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.

Soothing Day Cream SPF 15 CONSUMER LABELING

Active ingredients:

Avobenzone 2%

Octinoxate 7%

Octibenzone 5%

Purpose: Sunscreen

Keep out of children’s reach.

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.



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

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.

B. KAMINS

Soothing Day Cream SPF15

50mL / 1.7 fl.oz

DIN 02275791

SOOTHING DAY SPF 15 
avobenzone octinoxate oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63550-192
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE20 mg  in 1 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE70 mg  in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CETYL ALCOHOL 
POLYOXYL 100 STEARATE 
GLYCERYL MONOSTEARATE 
GLYCERIN 
SQUALANE 
ACER SACCHARUM SAP 
CETETH-16 
CETEARETH-12 
DIETHYLHEXYL 2,6-NAPHTHALATE 
QUADROSILAN 
CYCLOMETHICONE 5 
DIMETHICONE 
XANTHAN GUM 
.ALPHA.-TOCOPHEROL ACETATE, D- 
VITAMIN A PALMITATE 
SODIUM HYDROXIDE 
PHENOXYETHANOL 
CHLORPHENESIN 
Packaging
#Item CodePackage Description
1NDC:63550-192-0750 mL in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/19/2010
Labeler - Kamins Dermatologics Inc. (254050784)
Registrant - Kamins Dermatologics Inc. (254050784)
Establishment
NameAddressID/FEIOperations
Kamins Dermatologics Inc.254050784manufacture, pack, label

Revised: 10/2010
 
Kamins Dermatologics Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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