Skin Activator

Manufacturer: Cosmint Spa.
Effective date: 2011-11-23
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:30:12

Label at a glance#

ProductSkin Activator Lip Refiner SPF 15

Active ingredientOctinoxate, Octisalate, Avobenzone

Label structure5 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS
Octinoxate (7%)
Octisalate (5%)
Avobenzone (1.5%)

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS
Smooth onto lips daily.
Apply prior to sun exposure

WARNINGS SECTION

WARNINGS
For external use only.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.
Use on children under 2 years of age only with the advice of physician.

OTC - WHEN USING SECTION

Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

OTC - STOP USE SECTION

Discontinue use if signs of irritation or rush occurs. If irritation or rash persist, consult a doctor.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS

Water
Glycerin
Isopropyl isostearate
Beeswax (cera alba)
Diisopropyl dimer dilinoleate
Butyrospermum parkii (shea) butter
Dimethicone
Cetearyl alcohol
Ceteareth 20
Sodium pca
Squalane
Dipalmitoyl hydroxyproline
Glucosamine hydrochloride
Algae extract
Yeast extract
Urea
Ethylhexyl palmitate
Tribehenin
Sorbitan isostearate
Palmitoyl oligopeptide
Tocopherol acetate
Tetrahexyldecyl ascorbate
Bisabolol
Camellia sinensis leaf extract
Xanthan gum
Glyceryl stearate
Peg 100 stearate
Mentha piperita (peppermint) oil
Tetrasodium edta
Fragrance (parfum)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63509-002-01	2019-11-13	C162847	48780-1	97449f38-bfe4-f6ea-e053-dbdaa90aa703	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63509-002-01	Skin ActivatorLip Refiner SPF 15	15 mL in 1 TUBE	CREAM	15		2
63509-002-01	Skin ActivatorLip Refiner SPF 15	1 in 1 CARTON	CREAM	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63509-002	SKIN ACTIVATOR LIP REFINER SPF 15 (OCTINOXATE, OCTISALATE AND AVOBENZONE) CREAM [COSMINT SPA.]	2	Legacy NDC, 2 package rows	20111125_1ae7a670-34ff-4caa-bc06-932c18fd5931.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Avobenzone	ACTIVE INGREDIENT	G63QQF2NOX	2
Octinoxate	ACTIVE INGREDIENT	4Y5P7MUD51	2
Octisalate	ACTIVE INGREDIENT	4X49Y0596W	2
Avobenzone	ACTIVE MOIETY	G63QQF2NOX	2
Octinoxate	ACTIVE MOIETY	4Y5P7MUD51	2
Octisalate	ACTIVE MOIETY	4X49Y0596W	2
Alpha-Tocopherol Acetate	INACTIVE INGREDIENT	9E8X80D2L0	2
Cetostearyl Alcohol	INACTIVE INGREDIENT	2DMT128M1S	2
Diisopropyl Dilinoleate	INACTIVE INGREDIENT	5323S7S2LR	2
Dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	2
Dipalmitoyl hydroxyproline	INACTIVE INGREDIENT	E6AHA53N1H	2
Edetate Sodium	INACTIVE INGREDIENT	MP1J8420LU	2
Ethylhexyl palmitate	INACTIVE INGREDIENT	2865993309	2
Glucosamine hydrochloride	INACTIVE INGREDIENT	750W5330FY	2
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	2
Glyceryl Monostearate	INACTIVE INGREDIENT	230OU9XXE4	2
Green Tea Leaf	INACTIVE INGREDIENT	W2ZU1RY8B0	2
ISOPROPYL ISOSTEARATE	INACTIVE INGREDIENT	C67IXB9Y7T	2
Laminaria digitata	INACTIVE INGREDIENT	15E7C67EE8	2
Levomenol	INACTIVE INGREDIENT	24WE03BX2T	2
Palmitoyl oligopeptide	INACTIVE INGREDIENT	HO4ZT5S86C	2
PEG-100 Stearate	INACTIVE INGREDIENT	YD01N1999R	2
Peppermint oil	INACTIVE INGREDIENT	AV092KU4JH	2
Polyoxyl 20 Cetostearyl Ether	INACTIVE INGREDIENT	YRC528SWUY	2
Shea butter	INACTIVE INGREDIENT	K49155WL9Y	2
Sodium Pyrrolidone Carboxylate	INACTIVE INGREDIENT	469OTG57A2	2
Sorbitan isostearate	INACTIVE INGREDIENT	01S2G2C1E4	2
Squalane	INACTIVE INGREDIENT	GW89575KF9	2
Tetrahexyldecyl ascorbate	INACTIVE INGREDIENT	9LBV3F07AZ	2
Tribehenin	INACTIVE INGREDIENT	8OC9U7TQZ0	2
Urea	INACTIVE INGREDIENT	8W8T17847W	2
Water	INACTIVE INGREDIENT	059QF0KO0R	2
Xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	2
Yeast	INACTIVE INGREDIENT	3NY3SM6B8U	2
Yellow wax	INACTIVE INGREDIENT	2ZA36H0S2V	2

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

Skin Activator Lip Refiner SPF 15
Octinoxate, Octisalate and Avobenzone
Octinoxate
Octisalate
Avobenzone
Water
Glycerin
ISOPROPYL ISOSTEARATE
Yellow wax
Diisopropyl Dilinoleate
Shea butter
Dimethicone
Cetostearyl Alcohol
Polyoxyl 20 Cetostearyl Ether
Sodium Pyrrolidone Carboxylate
Squalane
Dipalmitoyl hydroxyproline
Glucosamine hydrochloride
Laminaria digitata
Yeast
Urea
Ethylhexyl palmitate
Tribehenin
Sorbitan isostearate
Palmitoyl oligopeptide
Alpha-Tocopherol Acetate
Tetrahexyldecyl ascorbate
Levomenol
Green Tea Leaf
Xanthan gum
Glyceryl Monostearate
PEG-100 Stearate
Peppermint oil
Edetate Sodium

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63509-002	63509-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Octinoxate	4Y5P7MUD51	ACTIB
Octisalate	4X49Y0596W	ACTIB
Avobenzone	G63QQF2NOX	ACTIB
Water	059QF0KO0R	IACT
Glycerin	PDC6A3C0OX	IACT
ISOPROPYL ISOSTEARATE	C67IXB9Y7T	IACT
Yellow wax	2ZA36H0S2V	IACT
Diisopropyl Dilinoleate	5323S7S2LR	IACT
Shea butter	K49155WL9Y	IACT
Dimethicone	92RU3N3Y1O	IACT
Cetostearyl Alcohol	2DMT128M1S	IACT
Polyoxyl 20 Cetostearyl Ether	YRC528SWUY	IACT
Sodium Pyrrolidone Carboxylate	469OTG57A2	IACT
Squalane	GW89575KF9	IACT
Dipalmitoyl hydroxyproline	E6AHA53N1H	IACT
Glucosamine hydrochloride	750W5330FY	IACT
Laminaria digitata	15E7C67EE8	IACT
Yeast	3NY3SM6B8U	IACT
Urea	8W8T17847W	IACT
Ethylhexyl palmitate	2865993309	IACT
Tribehenin	8OC9U7TQZ0	IACT
Sorbitan isostearate	01S2G2C1E4	IACT
Palmitoyl oligopeptide	HO4ZT5S86C	IACT
Alpha-Tocopherol Acetate	9E8X80D2L0	IACT
Tetrahexyldecyl ascorbate	9LBV3F07AZ	IACT
Levomenol	24WE03BX2T	IACT
Green Tea Leaf	W2ZU1RY8B0	IACT
Xanthan gum	TTV12P4NEE	IACT
Glyceryl Monostearate	230OU9XXE4	IACT
PEG-100 Stearate	YD01N1999R	IACT
Peppermint oil	AV092KU4JH	IACT
Edetate Sodium	MP1J8420LU	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 4 · 204 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Glycerin	GLYCERIN	PDC6A3C0OX	CREAM / VAGINAL		60 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Edetate Sodium	EDETATE SODIUM	MP1J8420LU	SOAP / TOPICAL	0.12 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
Xanthan gum	XANTHAN GUM	TTV12P4NEE	FILM, SOLUBLE / ORAL		1 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Yellow wax	YELLOW WAX	2ZA36H0S2V	TABLET / ORAL	3.22 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	225 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CREAM, AUGMENTED / TOPICAL		55 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Xanthan gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION, EXTENDED RELEASE / ORAL	186.8 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
Xanthan gum	XANTHAN GUM	TTV12P4NEE	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Xanthan gum	XANTHAN GUM	TTV12P4NEE	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Yellow wax	YELLOW WAX	2ZA36H0S2V	CAPSULE, EXTENDED RELEASE / ORAL	80.67 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
Edetate Sodium	EDETATE SODIUM	MP1J8420LU	INJECTION / INTRAVENOUS	0.01 %w/v		Exact identifier — unii candidate 12 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	AEROSOL, FOAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAMUSCULAR		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	DOUCHE / VAGINAL	1 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Edetate Sodium	EDETATE SODIUM	MP1J8420LU	SOLUTION / TOPICAL	0.3 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
Xanthan gum	XANTHAN GUM	TTV12P4NEE	AEROSOL, FOAM / TOPICAL	0.27 %w/w		Exact identifier — unii candidate 29 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CONCENTRATE / ORAL		1800 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / AURICULAR (OTIC)		25 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Peppermint oil	PEPPERMINT OIL	AV092KU4JH	POWDER, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
Xanthan gum	XANTHAN GUM	TTV12P4NEE	PASTE / ORAL		1050 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Yellow wax	YELLOW WAX	2ZA36H0S2V	CREAM / TOPICAL	5 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION / AURICULAR (OTIC)	0.05 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / ORAL		750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Peppermint oil	PEPPERMINT OIL	AV092KU4JH	SYRUP / ORAL		120 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAVENOUS		33750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Xanthan gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Edetate Sodium	EDETATE SODIUM	MP1J8420LU	INJECTION, SOLUTION / INTRAVENOUS	0.04 %w/v		Exact identifier — unii candidate 12 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	LOTION / TOPICAL		177 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Peppermint oil	PEPPERMINT OIL	AV092KU4JH	OINTMENT / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Peppermint oil	PEPPERMINT OIL	AV092KU4JH	GUM, CHEWING / ORAL		526 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Edetate Sodium	EDETATE SODIUM	MP1J8420LU	LOTION / TOPICAL	0.17 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
Xanthan gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / TOPICAL	0.11 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CAPSULE / ORAL		3487 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	GUM, CHEWING / BUCCAL		230 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET / ORAL	33.34 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
Urea	UREA	8W8T17847W	DOUCHE / VAGINAL	8 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, EMULSION / INTRAVENOUS		24100 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION / OPHTHALMIC		58 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Xanthan gum	XANTHAN GUM	TTV12P4NEE	TABLET, FILM COATED / ORAL	0.08 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CLOTH / TOPICAL	0.05 mg/mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Peppermint oil	PEPPERMINT OIL	AV092KU4JH	PASTE, DENTIFRICE / DENTAL	49.3 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
Xanthan gum	XANTHAN GUM	TTV12P4NEE	LOZENGE / ORAL		1264 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Xanthan gum	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		2350 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Peppermint oil	PEPPERMINT OIL	AV092KU4JH	GUM, CHEWING / BUCCAL		526 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Squalane	SQUALANE	GW89575KF9	AEROSOL, FOAM / TOPICAL	2.23 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
Urea	UREA	8W8T17847W	CREAM / VAGINAL	0.64 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
Cetostearyl Alcohol	CETOSTEARYL ALCOHOL	2DMT128M1S	LOTION / TOPICAL		3627 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	SUSPENSION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 21 equally ranked IID candidates
Xanthan gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / RECTAL		452 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Edetate Sodium	EDETATE SODIUM	MP1J8420LU	SOLUTION / OPHTHALMIC	0.1 %w/v		Exact identifier — unii candidate 12 equally ranked IID candidates
Polyoxyl 20 Cetostearyl Ether	POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	SUSPENSION / ORAL		20 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
Urea	UREA	8W8T17847W	SYSTEM / TOPICAL		840 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
Polyoxyl 20 Cetostearyl Ether	POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	AEROSOL / TOPICAL	5.5 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	ELIXIR / ORAL		5621 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Yellow wax	YELLOW WAX	2ZA36H0S2V	CAPSULE / ORAL		44 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
PEG-100 Stearate	PEG-100 MONOSTEARATE	YD01N1999R	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 3 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	JELLY / TOPICAL	NA		Exact identifier — unii candidate 75 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
b349a64f-70d7-4163-b618-9474fcd3408c			1ae7a670-34ff-4caa-bc06-932c18fd5931	2011-11-23	Warnings	Exact identifier spl id: b349a64f-70d7-4163-b618-9474fcd3408c spl set id: 1ae7a670-34ff-4caa-bc06-932c18fd5931

Reported adverse events (FAERS/openFDA)#

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