FDA.reportPublic FDA data

CC Cushion Compact SunScreen - Medium / Deep

Manufacturer
Skin Pi LLC
Effective date
2017-01-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:48:40

Label at a glance#

ProductCC Cushion Compact SunScreen - Medium / Deep
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure9 sections

Label contents#

Full prescribing information#

Active Ingredients: each 15 g contains

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide - 22.4%

Zinc Oxide - 0.5%

PURPOSE

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

USES: Help to prevent sunburn. If used as directed with other sun protection measures (see directions) may decrease the risk of skin cancer and early skin ageing caused by the sun.

WARNINGS SECTION

Warnings- For external use only. Do not use on damaged or broken skin.
When using this product: Keep out of the eyes. Rinse with water to remove.
Stop use and ask a doctor If rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out the of reach of children. If product is swallowed, get medical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION SECTION

Directions: Apply liberally 15 minutes before sun exposure.

Reapply

  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • atleast every 2 hours
  • children under 6 months: ask a doctor.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water(Aqua), Shea Butter, Jojoba Oil, Cucumber Extract, Grape Seed Oil, Yellow Beeswax, Chamomile Extract, Iron Oxide CI : 77492, Glycerin(and)Water(and) Dextran(and)Caprooyl Tetrapeptide-3, Mandelic Acid, Ascorbyl Glucoside, Aqua /Water (and) Tripleurospermum Maritimum Extract, Iron Oxide CI : 77491, Hyaluronic Acid, Iron Oxide CI : 77499, Phenoxyethanol, Vitamin-E.

SPL UNCLASSIFIED SECTION

Color Control

SunScreen Broad spectrum SPF50+

Covers . Brightens . Protects . Soothes . Hydrates

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Pharmacologic Classes#

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

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
71190-9387-42020-01-31C16284748780-19d75b9d0-9d60-f424-e053-dadaa90a57ceCC Cushion Compact SunScreen - Medium / Deep

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71190-9387-4CC Cushion Compact SunScreen - Medium / Deep15 g in 1 BOXCREAM151
71190-9387-4CC Cushion Compact SunScreen - Medium / Deep1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71190-9387CC CUSHION COMPACT SUNSCREEN - MEDIUM / DEEP (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SKIN PI LLC]1Legacy NDC, 2 package rows20170131_d96f9470-67d4-41da-9c5c-3ec3fbd9582e.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71190-938771190-9387-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM
WATER059QF0KO0RIACT
SHEA BUTTERK49155WL9YIACT
JOJOBA OIL724GKU717MIACT
CUCUMBERYY7C30VXJTIACT
GRAPE SEED OIL930MLC8XGGIACT
YELLOW WAX2ZA36H0S2VIACT
CHAMOMILEFGL3685T2XIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
GLYCERINPDC6A3C0OXIACT
DEXTRAN 40K3R6ZDH4DUIACT
CAPROOYL TETRAPEPTIDE-3LZI0HJ3K2RIACT
MANDELIC ACIDNH496X0UJXIACT
ASCORBYL GLUCOSIDE2V52R0NHXWIACT
TRIPLEUROSPERMUM INODORUM WHOLE567N54UG4SIACT
FERRIC OXIDE RED1K09F3G675IACT
HYALURONIC ACIDS270N0TRQYIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
PHENOXYETHANOLHIE492ZZ3TIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT

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
da63084a-81f7-421e-a45f-61a59a586f4bd96f9470-67d4-41da-9c5c-3ec3fbd9582e2017-01-20WarningsExact identifier
spl id: da63084a-81f7-421e-a45f-61a59a586f4b
spl set id: d96f9470-67d4-41da-9c5c-3ec3fbd9582e

Reported adverse events (FAERS/openFDA)#

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