FDA.reportPublic FDA data

Covergirl Aquasmooth

Manufacturer
Noxell Corporation | COTY US LLC
Effective date
2024-11-20
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 00:38:25

Label at a glance#

ProductCovergirl Aquasmooth Broadspectrum SPF 20 All shades
Active ingredientTITANIUM DIOXIDE
Label structure10 sections

Indications and uses

helps prevent sunburn 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 reapply at least every 2 hours use water resistant sunscreen if 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 sun, especially from 1...

Storage and handling

protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 9%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • 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 a 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
  • reapply at least every 2 hours
  • use water resistant sunscreen if 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 sun, especially from 10 a.m. – 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cyclopentasiloxane, water, butylene glycol, silica, niacinamide, tridecyl isononanoate, sorbitan isostearate, talc, euphorbia cerifera (candelilla) wax, ozokerite, tocopheryl acetate, panthenol, tocopherol, peg/ppg-18/18 dimethicone, dimethicone, phenoxyethanol, methicone, stearic acid, disodium edta, hydroxypropyl cyclodextrin, iodopropynyl butylcarbamate, sodium acetate, aluminum hydroxide, mica, titanium dioxide, iron oxides.

Questions?

OTC - QUESTIONS SECTION

Call 1-800-426-8374

PRINCIPAL DISPLAY PANEL - 12 g Case Blister Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

aqua smooth ®

makeup+
titanium dioxide sunscreen
broad spectrum SPF 20

705
ivory

COVERGIRL

Solid makeup that transforms into liquid for smooth coverage

12 g (.4 oz)

Principal Display Panel - 12 g Case Blister Pack
Principal Display Panel - 12 g Case Blister Pack

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
22700-084-12Covergirl AquasmoothBroadspectrum SPF 20 All shades12 g in 1 CASECREAM1210
22700-084-12Covergirl AquasmoothBroadspectrum SPF 20 All shades1 in 1 BLISTER PACKCREAM110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
22700-084COVERGIRL AQUASMOOTH BROADSPECTRUM SPF 20 ALL SHADES (TITANIUM DIOXIDE) CREAM [NOXELL CORPORATION]10Current NDC, Legacy NDC, 2 package rows20241122_952ea869-581e-4503-9f21-a77d061a417d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Titanium DioxideACTIVE INGREDIENT15FIX9V2JP2
Titanium DioxideACTIVE MOIETY15FIX9V2JP2
.alpha.-tocopherol acetateINACTIVE INGREDIENT9E8X80D2L02
aluminum hydroxideINACTIVE INGREDIENT5QB0T2IUN02
butylene glycolINACTIVE INGREDIENT3XUS85K0RA2
candelilla waxINACTIVE INGREDIENTWL0328HX192
Cyclomethicone 5INACTIVE INGREDIENT0THT5PCI0R2
dimethiconeINACTIVE INGREDIENT92RU3N3Y1O2
edetate disodiumINACTIVE INGREDIENT7FLD91C86K2
ferric oxide redINACTIVE INGREDIENT1K09F3G6752
iodopropynyl butylcarbamateINACTIVE INGREDIENT603P14DHEB2
micaINACTIVE INGREDIENTV8A1AW08802
niacinamideINACTIVE INGREDIENT25X51I8RD42
panthenolINACTIVE INGREDIENTWV9CM0O67Z2
peg/ppg-18/18 dimethiconeINACTIVE INGREDIENT9H0AO7T7942
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU42
sodium acetateINACTIVE INGREDIENT4550K0SC9B2
sorbitan isostearateINACTIVE INGREDIENT01S2G2C1E42
stearic acidINACTIVE INGREDIENT4ELV7Z65AP2
talcINACTIVE INGREDIENT7SEV7J4R1U2
tocopherolINACTIVE INGREDIENTR0ZB2556P82
waterINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
22700-08422700-084-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
TALC7SEV7J4R1UIACT
CYCLOMETHICONE 50THT5PCI0RIACT
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
NIACINAMIDE25X51I8RD4IACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
CANDELILLA WAXWL0328HX19IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PANTHENOLWV9CM0O67ZIACT
TOCOPHEROLR0ZB2556P8IACT
PEG/PPG-18/18 DIMETHICONE9H0AO7T794IACT
DIMETHICONE92RU3N3Y1OIACT
PHENOXYETHANOLHIE492ZZ3TIACT
STEARIC ACID4ELV7Z65APIACT
EDETATE DISODIUM7FLD91C86KIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
SODIUM ACETATE4550K0SC9BIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
MICAV8A1AW0880IACT
FERRIC OXIDE RED1K09F3G675IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 48 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
.alpha.-tocopherol acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
6 equally ranked IID candidates
Cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii+route
6 equally ranked IID candidates
butylene glycolBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii+route
2 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
phenoxyethanolPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4CREAM / VAGINAL51 mgExact identifier — unii+dosage form
4 equally ranked IID candidates
.alpha.-tocopherol acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
6 equally ranked IID candidates
sodium acetateSODIUM ACETATE4550K0SC9BCREAM / TOPICALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
phenoxyethanolPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4CREAM / VAGINAL51 mgExact identifier — unii+dosage form
4 equally ranked IID candidates
ferric oxide redFERRIC OXIDE RED1K09F3G675CREAM / TOPICALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
.alpha.-tocopherol acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
6 equally ranked IID candidates
talcTALC7SEV7J4R1UPOWDER / TOPICAL9235 mgExact identifier — unii+route
4 equally ranked IID candidates
talcTALC7SEV7J4R1UOINTMENT / TOPICAL74.6 %w/wExact identifier — unii+route
4 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii+route
4 equally ranked IID candidates
candelilla waxCANDELILLA WAXWL0328HX19TABLET, FILM COATED / ORAL0.8 mgExact identifier — unii candidate
8 equally ranked IID candidates
Cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii+route
6 equally ranked IID candidates
peg/ppg-18/18 dimethiconePEG/PPG-18/18 DIMETHICONE9H0AO7T794GEL / TOPICAL1 %w/wExact identifier — unii+route
2 equally ranked IID candidates
candelilla waxCANDELILLA WAXWL0328HX19TABLET, DELAYED RELEASE / ORAL1 mgExact identifier — unii candidate
8 equally ranked IID candidates
niacinamideNIACINAMIDE25X51I8RD4CREAM / TOPICALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
peg/ppg-18/18 dimethiconePEG/PPG-18/18 DIMETHICONE9H0AO7T794GEL / TOPICAL1 %w/wExact identifier — unii+route
2 equally ranked IID candidates
candelilla waxCANDELILLA WAXWL0328HX19TABLET, EXTENDED RELEASE / ORAL3 mgExact identifier — unii candidate
8 equally ranked IID candidates
aluminum hydroxideALUMINUM HYDROXIDE5QB0T2IUN0CREAM / TOPICAL5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
tocopherolTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
talcTALC7SEV7J4R1UOINTMENT / TOPICAL74.6 %w/wExact identifier — unii+route
4 equally ranked IID candidates
butylene glycolBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii+route
2 equally ranked IID candidates
.alpha.-tocopherol acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
6 equally ranked IID candidates
talcTALC7SEV7J4R1UPOWDER / TOPICAL9235 mgExact identifier — unii+route
4 equally ranked IID candidates
niacinamideNIACINAMIDE25X51I8RD4CREAM / TOPICALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
candelilla waxCANDELILLA WAXWL0328HX19TABLET, DELAYED RELEASE / ORAL1 mgExact identifier — unii candidate
8 equally ranked IID candidates
tocopherolTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
candelilla waxCANDELILLA WAXWL0328HX19TABLET, EXTENDED RELEASE / ORAL3 mgExact identifier — unii candidate
8 equally ranked IID candidates
.alpha.-tocopherol acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
6 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
candelilla waxCANDELILLA WAXWL0328HX19TABLET / ORAL4 mgExact identifier — unii candidate
8 equally ranked IID candidates
Cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii+route
6 equally ranked IID candidates
Cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii+route
6 equally ranked IID candidates
.alpha.-tocopherol acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
6 equally ranked IID candidates
candelilla waxCANDELILLA WAXWL0328HX19TABLET, FILM COATED / ORAL0.8 mgExact identifier — unii candidate
8 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii+route
4 equally ranked IID candidates
ferric oxide redFERRIC OXIDE RED1K09F3G675CREAM / TOPICALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii+route
6 equally ranked IID candidates
aluminum hydroxideALUMINUM HYDROXIDE5QB0T2IUN0CREAM / TOPICAL5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
candelilla waxCANDELILLA WAXWL0328HX19TABLET / ORAL4 mgExact identifier — unii candidate
8 equally ranked IID candidates
sodium acetateSODIUM ACETATE4550K0SC9BCREAM / TOPICALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii+route
6 equally ranked IID candidates

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
Covergirl Aquasmooth Broadspectrum SPF 20 All shadesTITANIUM DIOXIDENoxell Corporation952ea869-581e-4503-9f21-a77d061a417d2024-11-20WarningsExact identifier
ndc (package): 22700-084-12
ndc (product): 22700-084
ndc11 (package): 22700008412
spl id: 275a2567-029f-3742-e063-6294a90a2ceb
spl set id: 952ea869-581e-4503-9f21-a77d061a417d

Reported adverse events (FAERS/openFDA)#

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