ck one 3-in-1 face makeup

Manufacturer: Coty US LLC | Coty Inc. | Lancaster
Effective date: 2013-03-19
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:34:53

Label at a glance#

Productck one 3-in-1 face makeup with SPF 8 sunscreen 850 Toffee

Active ingredientTitanium Dioxide, Octinoxate

Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 2.0%

Titanium Dioxide 2.5%

OTC - PURPOSE SECTION

Sunscreen

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

WARNINGS SECTION

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, no skin cancer or early skin aging.

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure
Use a water resistant sunscreen if swimming or sweating
Reapply at least every 2 hours
Children under months: ask a doctor

INACTIVE INGREDIENT SECTION

aqua/water/eau, cyclopentasiloxane, neopentyl glycol diethylhexanoate, butylene glycol, hdi/trimethylol crosspolymer, mica, glycerin, vinyl dimethicone/methicone silsesquioxane crosspolymer, peg-10 dimethicone, caprylic/capric triglyceride, disteardimonium hectorite, phenoxyethanol, methyl methacrylate crosspolymer, caprylyl glycol, aluminum dimyristate, triethoxycaprylylsilane, parfum/fragrance, retinyl palmitate, sodium hyaluronate, tocopheryl acetate, silica, disodium stearoyl glutamate, ascorbyl glucoside, sorbic acid, alaria esculenta extract, tocopherol, bht, [may contain: iron oxides]

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Top Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Base Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66184-436-02	2019-11-27	C162847	48780-1	9855d018-d9d3-cd31-e053-dbdaa90ab51a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66184-436-01	ck one 3-in-1 face makeupwith SPF 8 sunscreen 850 Toffee	30 mL in 1 BOTTLE	LIQUID	30		1
66184-436-02	ck one 3-in-1 face makeupwith SPF 8 sunscreen 850 Toffee	1 in 1 BOX	LIQUID	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66184-436	CK ONE 3-IN-1 FACE MAKEUP WITH SPF 8 SUNSCREEN 850 TOFFEE (TITANIUM DIOXIDE AND OCTINOXATE) LIQUID [COTY US LLC]	1	Legacy NDC, 2 package rows	20130319_57192d6f-eea5-4544-b607-1d5d4eb4fec4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Octinoxate	ACTIVE INGREDIENT	4Y5P7MUD51	1
Titanium Dioxide	ACTIVE INGREDIENT	15FIX9V2JP	1
Octinoxate	ACTIVE MOIETY	4Y5P7MUD51	1
Titanium Dioxide	ACTIVE MOIETY	15FIX9V2JP	1
Alaria Esculenta	INACTIVE INGREDIENT	EJ9JK8J58D	1
Alpha-Tocopherol Acetate	INACTIVE INGREDIENT	9E8X80D2L0	1
Aluminum Dimyristate	INACTIVE INGREDIENT	J2KA067N9O	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	1
Butylene Glycol	INACTIVE INGREDIENT	3XUS85K0RA	1
Caprylyl Glycol	INACTIVE INGREDIENT	00YIU5438U	1
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	1
Disodium Stearoyl Glutamate	INACTIVE INGREDIENT	45ASM2L11M	1
Hyaluronate Sodium	INACTIVE INGREDIENT	YSE9PPT4TH	1
Methyl Methacrylate	INACTIVE INGREDIENT	196OC77688	1
Neopentyl Glycol	INACTIVE INGREDIENT	QI80HXD6S5	1
PEG-10 DIMETHICONE (600 CST)	INACTIVE INGREDIENT	8PR7V1SVM0	1
Phenoxyethanol	INACTIVE INGREDIENT	HIE492ZZ3T	1
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
Sorbic Acid	INACTIVE INGREDIENT	X045WJ989B	1
Tocopherol	INACTIVE INGREDIENT	R0ZB2556P8	1
Tricaprin	INACTIVE INGREDIENT	O1PB8EU98M	1
Triethoxycaprylylsilane	INACTIVE INGREDIENT	LDC331P08E	1
Vitamin A Palmitate	INACTIVE INGREDIENT	1D1K0N0VVC	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

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

ck one 3-in-1 face makeup with SPF 8 sunscreen 850 Toffee
Titanium Dioxide and Octinoxate
Titanium Dioxide
Octinoxate
Water
CYCLOMETHICONE 5
Neopentyl Glycol
Butylene Glycol
PEG-10 DIMETHICONE (600 CST)
Tricaprin
Phenoxyethanol
Methyl Methacrylate
Caprylyl Glycol
Aluminum Dimyristate
Triethoxycaprylylsilane
Vitamin A Palmitate
Hyaluronate Sodium
Alpha-Tocopherol Acetate
Silicon Dioxide
Disodium Stearoyl Glutamate
Sorbic Acid
Alaria Esculenta
Tocopherol
BUTYLATED HYDROXYTOLUENE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
66184-436	66184-436-01, 66184-436-02

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
Name	UNII	Kind
Titanium Dioxide	15FIX9V2JP	ACTIB
Octinoxate	4Y5P7MUD51	ACTIB
Water	059QF0KO0R	IACT
CYCLOMETHICONE 5	0THT5PCI0R	IACT
Neopentyl Glycol	QI80HXD6S5	IACT
Butylene Glycol	3XUS85K0RA	IACT
PEG-10 DIMETHICONE (600 CST)	8PR7V1SVM0	IACT
Tricaprin	O1PB8EU98M	IACT
Phenoxyethanol	HIE492ZZ3T	IACT
Methyl Methacrylate	196OC77688	IACT
Caprylyl Glycol	00YIU5438U	IACT
Aluminum Dimyristate	J2KA067N9O	IACT
Triethoxycaprylylsilane	LDC331P08E	IACT
Vitamin A Palmitate	1D1K0N0VVC	IACT
Hyaluronate Sodium	YSE9PPT4TH	IACT
Alpha-Tocopherol Acetate	9E8X80D2L0	IACT
Silicon Dioxide	ETJ7Z6XBU4	IACT
Disodium Stearoyl Glutamate	45ASM2L11M	IACT
Sorbic Acid	X045WJ989B	IACT
Alaria Esculenta	EJ9JK8J58D	IACT
Tocopherol	R0ZB2556P8	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT

Source Document#

Source XML

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 3 · 124 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
Tocopherol	TOCOPHEROL	R0ZB2556P8	CREAM / TOPICAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	LOTION / TOPICAL		1000 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Sorbic Acid	SORBIC ACID	X045WJ989B	TABLET / ORAL		10 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
Phenoxyethanol	PHENOXYETHANOL	HIE492ZZ3T	GEL / TOPICAL		14 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION, CONCENTRATE / ORAL	0.1 mg/1ml		Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	FILM, SOLUBLE / ORAL	0.06 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
Hyaluronate Sodium	HYALURONATE SODIUM	YSE9PPT4TH	INJECTION, SUSPENSION / INTRAVITREAL		23 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION / ORAL		200 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Hyaluronate Sodium	HYALURONATE SODIUM	YSE9PPT4TH	LOTION / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, LIQUID FILLED / ORAL		106 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	INSERT / VAGINAL		8 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM / TOPICAL		6 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Alpha-Tocopherol Acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	AEROSOL, FOAM / TOPICAL		4 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Sorbic Acid	SORBIC ACID	X045WJ989B	TABLET / SUBLINGUAL	0.16 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, EXTENDED RELEASE / ORAL		168 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Sorbic Acid	SORBIC ACID	X045WJ989B	TABLET, CHEWABLE / ORAL	NA		Exact identifier — unii candidate 19 equally ranked IID candidates
CYCLOMETHICONE 5	CYCLOMETHICONE 5	0THT5PCI0R	CREAM, AUGMENTED / TOPICAL		260 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING / ORAL		68 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Tocopherol	TOCOPHEROL	R0ZB2556P8	CAPSULE, COATED / ORAL	0.25 mg		Exact identifier — unii candidate 5 equally ranked IID candidates
Butylene Glycol	BUTYLENE GLYCOL	3XUS85K0RA	SYSTEM / TOPICAL		1400 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
Sorbic Acid	SORBIC ACID	X045WJ989B	SOLUTION/ DROPS / OPHTHALMIC	0.2 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
Sorbic Acid	SORBIC ACID	X045WJ989B	OINTMENT / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 19 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / VAGINAL	8 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE PARTICLES / ORAL		170 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM / VAGINAL	0.05 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
Sorbic Acid	SORBIC ACID	X045WJ989B	SOLUTION / OPHTHALMIC	0.2 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SPRAY, METERED / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 32 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SOLUTION / ORAL		280 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Sorbic Acid	SORBIC ACID	X045WJ989B	SUSPENSION / ORAL		40 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION / INTRAVENOUS	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SOLUTION / ORAL	1.8 mg/120ml		Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	SYSTEM / TRANSDERMAL		35 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, EXTENDED RELEASE / ORAL		450 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Phenoxyethanol	PHENOXYETHANOL	HIE492ZZ3T	CREAM, AUGMENTED / TOPICAL		10 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GUM, CHEWING / BUCCAL		5 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE / ORAL		254 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SHAMPOO / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / BUCCAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GEL, METERED / TOPICAL		4 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Tocopherol	TOCOPHEROL	R0ZB2556P8	CAPSULE / ORAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CREAM / VAGINAL		51 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, DELAYED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TAMPON / VAGINAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
Alpha-Tocopherol Acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
Sorbic Acid	SORBIC ACID	X045WJ989B	SOLUTION / ORAL		80 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GEL / TOPICAL		8 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SPRAY / TOPICAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SWAB / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	LOZENGE / ORAL		120 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / NASAL		20 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 49 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
a73079b6-4688-41b6-9290-cbb2b9a7180b			57192d6f-eea5-4544-b607-1d5d4eb4fec4	2013-03-19	Warnings	Exact identifier spl id: a73079b6-4688-41b6-9290-cbb2b9a7180b spl set id: 57192d6f-eea5-4544-b607-1d5d4eb4fec4

Reported adverse events (FAERS/openFDA)#

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