Label: SOOTHING DAY SPF 15- avobenzone octinoxate oxybenzone cream
- NDC Code(s): 63550-192-07
- 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
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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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.
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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.
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SOOTHING DAY SPF 15
avobenzone octinoxate oxybenzone creamProduct 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 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 Shape Size Flavor Imprint Code Contains 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)
