mally Lip Defender

Manufacturer: MallyGirl, LLC
Effective date: 2012-05-01
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:31:38

Label at a glance#

Productmally Lip Defender

Active ingredientAVOBENZONE, OCTINOXATE

Label structure12 sections

Dosage and administration

Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: ask a doctor. Sun Protection Measures. Spending time in the sun increases risk of skin cancer and early aging. To decrease this risk regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higer and other sun protection measures including: Limi...

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.0%

Octinoxate 7.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

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 SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - STOP USE SECTION

Stop use and ask doctor if rash occurs.

OTC - WHEN USING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

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 6 months: ask a doctor.
Sun Protection Measures. Spending time in the sun increases risk of skin cancer and early aging. To decrease this risk regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higer and other sun protection measures including:
Limit time in the sun especially from 10:00 a.m. - 2:00 p.m.
Wear long sleeved shirts, pants, hats and sunglasses

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Polybutene, Helianthus annuus (sunflower) seed oil, Polyglyceryl-2 triisostearate, Octyldecanol, Euphorbia cerifera (candelilla) wax (candelilla cera), Trihydroxystearin, Copernicia cerifera (carnauba) wax (cera carnauba), Microcrystalline wax (microcristallina cera), Phospholipids, Calcium aluminum borosilicate, Calcium sodium borosilicate, Tocopheryl acetate, Silica, Sodium chondroitin sulfate, Saccharomyces cerevisiae extract, Hyaluronic acid, Tocopherol, Alumina, Tripeptide-29, Tin oxide, Titanium dioxide (CI 77891) May Contain: Mica (CI 77019), Red 28 Lake (CI 45410), Yellow 5 Lake (CI 19140), Red 6 (CI 15850), Red 7 Lake (CI 15850), Yellow 6 Lake (CI 15985), Iron Oxides (CI 77491, CI 77492, CI 77499), Blue 1 Lake (CI 42090)

Other Information

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

mally

Lip Defender
Empowering Pink
duos with sunscreen
Broad Spectrum SPF 15

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76119-5305-1	2019-11-13	C162847	48780-1	97449f38-d0f4-f6ea-e053-dbdaa90aa703	mally Lip Defender - Empowering Pink - Broad Spectrum SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76119-5305-1	mally Lip Defender	3.5 g in 1 TUBE, WITH APPLICATOR	GEL	3.5		1
76119-5305-1	mally Lip Defender	1 in 1 BOX	GEL	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76119-5305	MALLY LIP DEFENDER (AVOBENZONE, OCTINOXATE) GEL [MALLYGIRL, LLC]	1	Legacy NDC, 2 package rows	20120503_6262a1d6-62dc-4c82-96f1-c9e252d6afeb.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	1
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	1
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	1
CANDELILLA WAX	INACTIVE INGREDIENT	WL0328HX19	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	1
D&C RED NO. 6	INACTIVE INGREDIENT	481744AI4O	1
D&C RED NO. 7	INACTIVE INGREDIENT	ECW0LZ41X8	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	1
HYALURONIC ACID	INACTIVE INGREDIENT	S270N0TRQY	1
MICA	INACTIVE INGREDIENT	V8A1AW0880	1
MICROCRYSTALLINE WAX	INACTIVE INGREDIENT	XOF597Q3KY	1
OCTYLDECANOL	INACTIVE INGREDIENT	07UG7TSU58	1
POLYBUTENE (1400 MW)	INACTIVE INGREDIENT	1NA5AO9GH7	1
SACCHAROMYCES CEREVISIAE	INACTIVE INGREDIENT	978D8U419H	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW)	INACTIVE INGREDIENT	H5BJH23Z9A	1
STANNIC OXIDE	INACTIVE INGREDIENT	KM7N50LOS6	1
SUNFLOWER OIL	INACTIVE INGREDIENT	3W1JG795YI	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	1
TRIHYDROXYSTEARIN	INACTIVE INGREDIENT	06YD7896S3	1

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

mally Lip Defender
AVOBENZONE, OCTINOXATE
AVOBENZONE
OCTINOXATE
POLYBUTENE (1400 MW)
SUNFLOWER OIL
OCTYLDECANOL
CANDELILLA WAX
TRIHYDROXYSTEARIN
CARNAUBA WAX
MICROCRYSTALLINE WAX
.ALPHA.-TOCOPHEROL ACETATE
SILICON DIOXIDE
SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW)
SACCHAROMYCES CEREVISIAE
HYALURONIC ACID
TOCOPHEROL
ALUMINUM OXIDE
STANNIC OXIDE
TITANIUM DIOXIDE
MICA
D&C RED NO. 28
FD&C YELLOW NO. 5
D&C RED NO. 6
D&C RED NO. 7
FD&C YELLOW NO. 6
FERRIC OXIDE RED
FD&C BLUE NO. 1

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
76119-5305	76119-5305-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
AVOBENZONE	G63QQF2NOX	ACTIB
OCTINOXATE	4Y5P7MUD51	ACTIB
POLYBUTENE (1400 MW)	1NA5AO9GH7	IACT
SUNFLOWER OIL	3W1JG795YI	IACT
OCTYLDECANOL	07UG7TSU58	IACT
CANDELILLA WAX	WL0328HX19	IACT
TRIHYDROXYSTEARIN	06YD7896S3	IACT
CARNAUBA WAX	R12CBM0EIZ	IACT
MICROCRYSTALLINE WAX	XOF597Q3KY	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW)	H5BJH23Z9A	IACT
SACCHAROMYCES CEREVISIAE	978D8U419H	IACT
HYALURONIC ACID	S270N0TRQY	IACT
TOCOPHEROL	R0ZB2556P8	IACT
ALUMINUM OXIDE	LMI26O6933	IACT
STANNIC OXIDE	KM7N50LOS6	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
MICA	V8A1AW0880	IACT
D&C RED NO. 28	767IP0Y5NH	IACT
FD&C YELLOW NO. 5	I753WB2F1M	IACT
D&C RED NO. 6	481744AI4O	IACT
D&C RED NO. 7	ECW0LZ41X8	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
FD&C BLUE NO. 1	H3R47K3TBD	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 5 · 254 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	INSERT, EXTENDED RELEASE / OPHTHALMIC	0.4 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	140 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	FILM / SUBLINGUAL	0.07 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	LIQUID / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SPONGE / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL		166 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, DELAYED RELEASE / ORAL		66 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, ORALLY DISINTEGRATING / ORAL		2 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	LOZENGE / ORAL		120 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MICROCRYSTALLINE WAX	MICROCRYSTALLINE WAX	XOF597Q3KY	GEL / TOPICAL	NA		Exact identifier — unii candidate 4 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, DELAYED RELEASE / ORAL	230 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	ELIXIR / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED PELLETS / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, FILM COATED / ORAL		3 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SHAMPOO / TOPICAL	0.75 %w/w		Exact identifier — unii candidate 37 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING / ORAL		68 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SUSPENSION / ORAL		11 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SOLUTION / RECTAL	0.5 %w/v		Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	POWDER, FOR SUSPENSION / ORAL		6 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / RESPIRATORY (INHALATION)	2 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE / ORAL		1190 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER, FOR SUSPENSION / ORAL		297 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LOTION / TOPICAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / DENTAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, FILM COATED / ORAL	1 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, COATED / ORAL	3.17 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	OINTMENT / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE / ORAL	26.3 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
ALUMINUM OXIDE	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, EXTENDED RELEASE / ORAL		67 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
D&C RED NO. 7	D&C RED NO. 7	ECW0LZ41X8	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	CAPSULE, EXTENDED RELEASE / ORAL	0.2 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / ORAL		72 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	GUM, CHEWING / BUCCAL		10 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE, COATED / ORAL	0.03 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / DENTAL	19 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, COATED / ORAL	0.52 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / BUCCAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	TABLET / ORAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	FILM / SUBLINGUAL	0.03 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
MICROCRYSTALLINE WAX	MICROCRYSTALLINE WAX	XOF597Q3KY	OINTMENT / TOPICAL		3575 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	POWDER / ORAL	20 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	DROPS / ORAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	GEL / TOPICAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, ORALLY DISINTEGRATING / ORAL		12 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, EXTENDED RELEASE / ORAL		450 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE / DENTAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
D&C RED NO. 7	D&C RED NO. 7	ECW0LZ41X8	TABLET / SUBLINGUAL	0.01 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL		750 mg	Exact identifier — unii candidate 49 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
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / SUBLINGUAL	0.03 mg		Exact identifier — unii candidate 37 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
e0107e7b-3575-471e-a011-5869c6a0d874			6262a1d6-62dc-4c82-96f1-c9e252d6afeb	2012-05-01	Warnings	Exact identifier spl id: e0107e7b-3575-471e-a011-5869c6a0d874 spl set id: 6262a1d6-62dc-4c82-96f1-c9e252d6afeb

Reported adverse events (FAERS/openFDA)#

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