CALMPOSE REPAIRY LIGHT DERMA SUN- zinc oxide cream 
Ecoment

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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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

Image of carton

CALMPOSE REPAIRY LIGHT DERMA SUN 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78958-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION9.2 g  in 40 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Dicaprylyl Carbonate (UNII: 609A3V1SUA)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78958-010-021 in 1 CARTON10/01/2020
1NDC:78958-010-0140 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/2020
Labeler - Ecoment (688485136)
Registrant - Ecoment (688485136)
Establishment
NameAddressID/FEIBusiness Operations
Ecoment688485136manufacture(78958-010)

Revised: 10/2020
Document Id: 6a64ecda-5ebf-44ab-a768-fd326a483a84
Set id: 7ef6171c-c71c-46de-bc46-dd02384231d9
Version: 1
Effective Time: 20201030
 
Ecoment