calmpose Repairy Light Derma Sun

Manufacturer
Ecoment
Effective date
2020-10-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:32:36

Label at a glance#

Productcalmpose Repairy Light Derma Sun
Active ingredientZinc Oxide
Label structure7 sections

Indications and 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

Dosage and administration

■ 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 absorp...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 23%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Sunscreen

WARNINGS

WARNINGS SECTION

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

INDICATIONS & USAGE SECTION

■ 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

DOSAGE & ADMINISTRATION SECTION

■ 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 cartonImage of carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138806158552239GTIN-13: 8806158552239
EAN-13: 8806158552239
GTIN storage (14 digits): 08806158552239
sun carton.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78958-010-022022-01-28C16284748780-1d6a99b39-49d6-a426-e053-dadaa90af4c27ef6171c-c71c-46de-bc46-dd02384231d9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78958-010-01calmpose Repairy Light Derma Sun40 mL in 1 CONTAINERCREAM401
78958-010-02calmpose Repairy Light Derma Sun1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78958-010CALMPOSE REPAIRY LIGHT DERMA SUN (ZINC OXIDE) CREAM [ECOMENT]1Legacy NDC, 2 package rows20201030_7ef6171c-c71c-46de-bc46-dd02384231d9.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78958-01078958-010-01, 78958-010-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
6a64ecda-5ebf-44ab-a768-fd326a483a847ef6171c-c71c-46de-bc46-dd02384231d92020-10-30WarningsExact identifier
spl id: 6a64ecda-5ebf-44ab-a768-fd326a483a84
spl set id: 7ef6171c-c71c-46de-bc46-dd02384231d9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.