Label: DERMATOUCH HYDRATING CLEAR MOISUTRIZER SPF 25- avobenzone, homosalate, octisalate lotion
- NDC Code(s): 68062-8309-1
- Packager: Spa de Soleil
- 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 January 18, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
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Warnings
Warnings:
. For external use only. . Do not use on damaged or broken skin.
. When using this product keep out of eyes. Rinse with water to remove.
. Stop use and ask a doctor if rash or irritation occurs or lasts.
. If swallowed, seek medical help or contact a poison control center right away.
. Keep out of reach of children.
. Jar is glass and may shatter if dropped.
- Directions
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Inactive Ingredients
Inactive Ingredients: Aqua, SD Alcohol 40-B, Glycerin, Cetearyl Ethylhexanoate, Ammonium Polyacryloyldimethyl Taurate, *CO Glycerin, *CO Humulus Lupulus (Hops) Extract, *CO Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, *CO Calendula Officinalis Flower Extract, *CO Chamomilla Recutita (Matricaria) Flower Extract, *CO Citrus Limon (Lemon) Peel Extract, *CO Cucumis Sativus (Cucumber) Seed Extract, *CO Camellia Sinensis Leaf Extract, *CO Pyrus Malus (Apple) Fruit Extract, *CO Spirulina Platensis Extract, Phenoxyethanol, Ethylhexylglycerin *Certified Organic
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
DERMATOUCH HYDRATING CLEAR MOISUTRIZER SPF 25
avobenzone, homosalate, octisalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68062-8309 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.5 mg in 50 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.5 mg in 50 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7.5 mg in 50 mL Inactive Ingredients Ingredient Name Strength LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) MATRICARIA CHAMOMILLA LEAF (UNII: 6I9LN466F0) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68062-8309-1 50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/18/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/18/2022 Labeler - Spa de Soleil (874682867) Establishment Name Address ID/FEI Business Operations Spa de Soleil 874682867 manufacture(68062-8309)