Label: CALMPOSE REPAIRY LIGHT DERMA SUN- zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 78958-010-01, 78958-010-02 - Packager: Ecoment
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 October 30, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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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
- WARNINGS
- Uses
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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
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INGREDIENTS AND APPEARANCE
CALMPOSE REPAIRY LIGHT DERMA SUN
zinc oxide creamProduct 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)
