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

Dermatouch Hydrating Clear Moisutrizer SPF 25 by

Drug Labeling and Warnings

Dermatouch Hydrating Clear Moisutrizer SPF 25 by is a Otc medication manufactured, distributed, or labeled by Spa de Soleil. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INDICATIONS & USAGE

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

KEEP OUT OF REACH OF CHILDREN

Principal Display Panel

INGREDIENTS AND APPEARANCE

DERMATOUCH HYDRATING CLEAR MOISUTRIZER SPF 25 
avobenzone, homosalate, octisalate lotion

Product 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)