CALMPOSE REPAIRY LIGHT DERMA SUN- zinc oxide cream

calmpose Repairy Light Derma Sun by

Drug Labeling and Warnings

calmpose Repairy Light Derma Sun by is a Otc medication manufactured, distributed, or labeled by Ecoment. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 23%

INACTIVE INGREDIENTS

Water, Dicaprylyl Carbonate, Caprylic/Capric Triglyceride, CentellaAsiatica Extract, Polyglyceryl-3 Diisostearate, Polyglyceryl-2 Dipolyhydroxystearate, Silica, SimmondsiaChinensis (Jojoba) Seed Oil, Pentylene Glycol, *Beeswax, Sodium Chloride, Dicaprylyl Ether, Glycerin, Betaine, Sodium Levulinate, GlycerylCaprylate, Sodium Anisate, Madecassoside, Squalane, Helianthus Annuus (Sunflower) Seed Oil, Asiaticoside, Propanediol, ButyrospermumParkii (Shea) Butter, TriticumVulgare (Wheat) Germ Oil, Sodium Hyaluronate, Hydrolyzed Hyaluronic Acid, Hyaluronic Acid, Ceramide NP, Phytosphingosine, Polyglutamic Acid, ChamomillaRecutita (Matricaria) Flower Extract, RobiniaPseudoacacia Flower Extract, PrunusYedoensis Flower Extract, Rosa Multiflora Flower Extract, Rhamnose, Glucose, Glucuronic Acid, PyrusCommunis (Pear) Fruit Extract, Rosa Damascena Flower Water, Iris Florentina Root Extract, CucumisMelo (Melon) Fruit Extract, Hedera Helix (Ivy) Leaf/Stem Extract, Tocopherol

PURPOSE

Sunscreen

WARNINGS

For external use only
Avoid contact with eyes.
Discontinue use if signs of irritation or rashes appear.
Replace the cap after use.
Keep out of reach of children

Uses

■ Helps prevent sun burn
■ If used as directed with other sun protection measures [see Direction] decrease the risk of skin cancer and early skin aging caused by the sun

Directions

■ Apply liberally and uniformly to all exposed areas10 minutes before sun exposure.
■ Reapply often (every 2 hours) and after swimming, excessive perspiration and washing to ensure maximum sun protection.
■ Put a drop of the product on your palm (size of a nut) and dot it onto your face using fingertips. Spread the sunscreen to cover all areas of your face using a massaging motion with your hands until full absorption into the skin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CALMPOSE REPAIRY LIGHT DERMA SUN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78958-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	9.2 g  in 40 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Dicaprylyl Carbonate (UNII: 609A3V1SUA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78958-010-02	1 in 1 CARTON	10/01/2020
1	NDC: 78958-010-01	40 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/01/2020

Labeler - Ecoment (688485136)

Registrant - Ecoment (688485136)

Establishment
Name	Address	ID/FEI	Business Operations
Ecoment		688485136	manufacture(78958-010)