DERMATOUCH HYDRATING CLEAR MOISUTRIZER SPF 25- avobenzone, homosalate, octisalate lotion 
Spa de Soleil

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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Dermatouch Hydrating Clear Moisutrizer SPF 25

Active Ingredients

Avobenzone 3.0%

Homosalate 15.0%

Octisalate 5.0%

Purpose

Sunscreen

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

Directions: Apply generously and evenly thirty minutes before sun exposure. Reapply at least every two hours. Use a water-resistant sunscreen if swimming or sweating. Children under six months of age: Consult a doctor.

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

Uses: . Helps prevent sunburn. . Higher SPF gives more sunburn protection. . If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

KEEP OUT OF REACH OF CHILDREN

Principal Display Panel

DermatouchSPF25fda.jpg

DERMATOUCH HYDRATING CLEAR MOISUTRIZER SPF 25 
avobenzone, homosalate, octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68062-8309
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.5 mg  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 mg  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7.5 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
MATRICARIA CHAMOMILLA LEAF (UNII: 6I9LN466F0)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68062-8309-150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/18/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/18/2022
Labeler - Spa de Soleil (874682867)
Establishment
NameAddressID/FEIBusiness Operations
Spa de Soleil874682867manufacture(68062-8309)

Revised: 1/2022
Document Id: d5f8805e-00db-56fe-e053-2a95a90aed52
Set id: d5f8805e-00da-56fe-e053-2a95a90aed52
Version: 1
Effective Time: 20220118
 
Spa de Soleil