FDA.reportPublic FDA data

CC Total Cover Cushion

Manufacturer
THEFACESHOP Co., Ltd. | ZENISCE Co., Ltd.
Effective date
2021-01-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:37:48

Label at a glance#

ProductCC Total Cover Cushion SPF 50 Natural Beige
Active ingredientTITANIUM DIOXIDE, ENSULIZOLE
Label structure14 sections

Indications and uses

Helps prevent sunbrun If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

Apply liberally 15 minutes before sun exposure and as needed. Reapply as needed or after towel drying, swimming, or sweating. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: - Limit time in the sun, especially from 1...

Storage and handling

Protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Ensulizole 2.7%

Titanium Dioxide 5.46%

PURPOSE

OTC - PURPOSE SECTION

SUNSCREEN

USES

INSTRUCTIONS FOR USE SECTION

  • Helps prevent sunbrun
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

WARNINGS

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use ​on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove

OTC - STOP USE SECTION

Stop use and ask doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure and as needed.
  • Reapply as needed or after towel drying, swimming, or sweating.
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

- Limit time in the sun, especially from 10 a.m. to 2 p.m.

- Wear long-sleeved shirts, pants, hats, and sunglasses

  • Children under 6 months: Ask a doctor

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER, CYCLOPENTASILOXANE, PHENYL TRIMETHICONE, TRIETHYLHEXANOIN, CYCLOHEXASILOXANE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, DIPENTAERYTHRITYL HEXA C5-9 ACID ESTERS, CETYL PEG/PPG-10/1 DIMETHICONE, NIACINAMIDE, BUTYLENE GLYCOL, TROMETHAMINE, DIMETHICONE, 1,2-HEXANEDIOL, SORBITAN SESQUIOLEATE, PEG-30 DIPOLYHYDROXYSTEARATE, ZINC STEARATE, STEARIC ACID, SODIUM CHLORIDE, DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER, GLYCERIN, DISTEARDIMONIUM HECTORITE, ALUMINUM HYDROXIDE, DISTEARYLDIMONIUM CHLORIDE, HYALURONIC ACID, DIMETHICONOL, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, DIMETHICONE CROSSPOLYMER, LAURYL DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER, PALMITOYL PROLINE, POLYMETHYLSILSESQUIOXANE, ADENOSINE, TRIETHOXYCAPRYLYLSILANE, SODIUM PALMITOYL SARCOSINATE, MAGNESIUM PALMITOYL GLUTAMATE, PALMITIC ACID, DIPROPYLENE GLYCOL, BORON NITRIDE, SODIUM CITRATE, TOCOPHEROL, SODIUM LAUROYL LACTYLATE, CERAMIDE NP, PHENOXYETHANOL, PHYTOSPHINGOSINE, CHOLESTEROL, CERAMIDE AP, ETHYLHEXYLGLYCERIN, XANTHAN GUM, CARBOMER, CERAMIDE EOP, FRAGRANCE, TITANIUM DIOXIDE(CI 77891), MICA, IRON OXIDES(CI 77491, CI 77492, CI 77499)

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Call toll free 1-888-498-9004

PRINCIPAL DISPLAY PANEL CC TOTAL COVER CUSHION BROAD SPECTRUM SPF 50 THEFACESHOP Net Wt. 0.52 oz | 15g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

V203V203

THEFACESHOP CC TOTAL COVER CUSHION V203 NATURAL BEIGE [Broad Spectrum SPF 50] Net Wt. 0.52 oz | 15 g.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

V203BTMV203BTM

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51523-061-032022-07-29C16284748780-1ba0f9c33-2d12-a910-e053-dadaa90a0b8568151e47-2f65-5670-e053-2a91aa0ad1bf
51523-061-032021-02-04C16284748780-1ba0f9c33-2d12-a910-e053-dadaa90a0b8568151e47-2f65-5670-e053-2a91aa0ad1bf
51523-061-032021-01-29C16284748780-1ba0f9c33-2d12-a910-e053-dadaa90a0b8568151e47-2f65-5670-e053-2a91aa0ad1bf

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51523-061-03CC Total Cover CushionSPF 50 Natural Beige15 g in 1 CONTAINERPOWDER152
51523-061-03CC Total Cover CushionSPF 50 Natural Beige2 in 1 BOXPOWDER22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51523-061CC TOTAL COVER CUSHION SPF 50 NATURAL BEIGE (ENSULIZOLE, TITANIUM DIOXIDE) POWDER [THEFACESHOP CO., LTD.]2Legacy NDC, 2 package rows20210206_68151e47-2f65-5670-e053-2a91aa0ad1bf.zip

Products#

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

DailyMed product names page 1 of 2 · 54 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51523-06151523-061-03

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 51 matching rows.

Name, UNII, Kind table
NameUNIIKind
CERAMIDE 15THT33P7X7IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PALMITOYL PROLINEI49727TDYFIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
ADENOSINEK72T3FS567IACT
MAGNESIUM PALMITOYL GLUTAMATEDH37YM1F48IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
PALMITIC ACID2V16EO95H1IACT
CYCLOMETHICONE 6XHK3U310BAIACT
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE75D21FL1PIIACT
MICAV8A1AW0880IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
SODIUM PALMITOYL SARCOSINATE7297LY09YFIACT
DIPENTAERYTHRITYL HEXA C5-9 ACID ESTERSD818OLQ51ZIACT
DIMETHICONE92RU3N3Y1OIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT
ENSULIZOLE9YQ9DI1W42ACTIB
GLYCERINPDC6A3C0OXIACT
DIMETHICONOL (100000 CST)OSA9UP217SIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)H895X08VNQIACT
ZINC STEARATEH92E6QA4FVIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
DISTEARYLDIMONIUM CHLORIDEOM9573ZX3XIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
TRIETHYLHEXANOIN7K3W1BIU6KIACT
HYALURONIC ACIDS270N0TRQYIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)V2W71V8T0XIACT
NIACINAMIDE25X51I8RD4IACT
TROMETHAMINE023C2WHX2VIACT
STEARIC ACID4ELV7Z65APIACT
PEG-30 DIPOLYHYDROXYSTEARATE9713Q0S7FOIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
DIPROPYLENE GLYCOLE107L85C40IACT
SODIUM CITRATE1Q73Q2JULRIACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT

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
ba883c5c-20cd-86d9-e053-2995a90aec1c68151e47-2f65-5670-e053-2a91aa0ad1bf2021-01-01WarningsExact identifier
spl id: ba883c5c-20cd-86d9-e053-2995a90aec1c
spl set id: 68151e47-2f65-5670-e053-2a91aa0ad1bf

Reported adverse events (FAERS/openFDA)#

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