Alba Very Emollient Sunscreen Lip Care SPF25

Manufacturer: Autumn Harp, Inc.
Effective date: 2013-09-17
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:39:45

Label at a glance#

ProductAlba Very Emollient Sunscreen Lip Care SPF25

Active ingredientOCTOCRYLENE, OCTINOXATE, OCTISALATE, ZINC OXIDE

Label structure9 sections

Indications and uses

• Helps prevent sunburn

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Children under 6 months: ask a doctor.

Contacts and useful links#

PhoneLabel contact(888) 659-7730

Websitewww.albabotanica.com

www.albabotanica.com

Label contents#

Full prescribing information#

Active Ingredient

WARNINGS AND PRECAUTIONS SECTION

Octocrylene 10.0%

Ethylhexyl Methoxycinnamate 7.5%

Zinc Oxide 3.7%

Ethylhexyl Salicylate 1.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

• Helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask doctor if skin rash occurs. Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging.

Directions

INSTRUCTIONS FOR USE SECTION

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Children under 6 months: ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Beeswax*, Helianthus Annuus (Sunflower) Seed Oil*, Simmondsia Chinensis (Jojoba) Seed Oil*, Olea Europaea (Olive) Fruit Oil*, Ricinus Communis (Castor) Seed Oil*, C12-15 Alkyl Benzoate, Flavor*, Euphorbia Cerifera (Candelilla) Wax, Copernicia Cerifera (Carnauba) Wax*, Butyrospermum Parkii (Shea Butter)*, Theobroma Cacao (Cocoa) Seed Butter*, Glycine Soya (Soybean) Oil, Oenothera Biennis (Evening Primrose) Oil, Aloe Barbadensis Leaf Extract*, Calendula Officinalis Flower Extract, Echinacea Purpurea Extract, Allantoin, Ammonium Glycyrrhizate, Tocopherol, Polyhydroxystearic Acid, Triethoxycaprylylsilane, Iron Oxides (CI 77491), * Certified Organic Ingredient

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun

Questions?

OTC - QUESTIONS SECTION

Call (888) 659-7730 or visit www.albabotanica.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image Components

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51514-0306-1	2019-11-27	C162847	48780-1	9855d018-e168-cd31-e053-dbdaa90ab51a	Alba Very Emollient Sunscreen Lip Care SPF25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51514-0306	ALBA VERY EMOLLIENT SUNSCREEN LIP CARE SPF25 (OCTOCRYLENE, OCTINOXATE, OCTISALATE, ZINC OXIDE) STICK [AUTUMN HARP, INC.]	1	Legacy NDC	20130920_0f2b43ae-a05b-44d6-b002-ac78fead5d83.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	1
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	1
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	1
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	1
ZINC Oxide	ACTIVE MOIETY	SOI2LOH54Z	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	1
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	1
Aloe Vera Leaf	INACTIVE INGREDIENT	ZY81Z83H0X	1
AMMONIUM GLYCYRRHIZATE	INACTIVE INGREDIENT	3VRD35U26C	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	1
C12-15 ALKYL BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	1
CALENDULA OFFICINALIS FLOWER	INACTIVE INGREDIENT	P0M7O4Y7YD	1
CANDELILLA WAX	INACTIVE INGREDIENT	WL0328HX19	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	1
CASTOR OIL	INACTIVE INGREDIENT	D5340Y2I9G	1
COCOA BUTTER	INACTIVE INGREDIENT	512OYT1CRR	1
ECHINACEA PURPUREA	INACTIVE INGREDIENT	QI7G114Y98	1
EVENING PRIMROSE OIL	INACTIVE INGREDIENT	3Q9L08K71N	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	1
JOJOBA OIL	INACTIVE INGREDIENT	724GKU717M	1
OLIVE OIL	INACTIVE INGREDIENT	6UYK2W1W1E	1
POLYHYDROXYSTEARIC ACID (2300 MW)	INACTIVE INGREDIENT	YXH47AOU0F	1
SHEA BUTTER	INACTIVE INGREDIENT	K49155WL9Y	1
SOYBEAN OIL	INACTIVE INGREDIENT	241ATL177A	1
SUNFLOWER OIL	INACTIVE INGREDIENT	3W1JG795YI	1
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	1
TRIETHOXYCAPRYLYLSILANE	INACTIVE INGREDIENT	LDC331P08E	1
VANILLA	INACTIVE INGREDIENT	Q74T35078H	1
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	1

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

Alba Very Emollient Sunscreen Lip Care SPF25
Octocrylene, Octinoxate, Octisalate, Zinc Oxide
OCTOCRYLENE
OCTINOXATE
OCTISALATE
ZINC OXIDE
YELLOW WAX
SUNFLOWER OIL
JOJOBA OIL
CASTOR OIL
OLIVE OIL
C12-15 ALKYL BENZOATE
VANILLA
CANDELILLA WAX
CARNAUBA WAX
SHEA BUTTER
COCOA BUTTER
AMMONIUM GLYCYRRHIZATE
POLYHYDROXYSTEARIC ACID (2300 MW)
SOYBEAN OIL
TOCOPHEROL
TRIETHOXYCAPRYLYLSILANE
EVENING PRIMROSE OIL
ALLANTOIN
ECHINACEA PURPUREA
CALENDULA OFFICINALIS FLOWER
BUTYLATED HYDROXYTOLUENE
FERRIC OXIDE RED
Aloe Vera Leaf
.ALPHA.-TOCOPHEROL ACETATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51514-0306	51514-0306-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OCTOCRYLENE	5A68WGF6WM	ACTIB
OCTINOXATE	4Y5P7MUD51	ACTIB
OCTISALATE	4X49Y0596W	ACTIB
ZINC OXIDE	SOI2LOH54Z	ACTIB
YELLOW WAX	2ZA36H0S2V	IACT
SUNFLOWER OIL	3W1JG795YI	IACT
JOJOBA OIL	724GKU717M	IACT
CASTOR OIL	D5340Y2I9G	IACT
OLIVE OIL	6UYK2W1W1E	IACT
C12-15 ALKYL BENZOATE	A9EJ3J61HQ	IACT
VANILLA	Q74T35078H	IACT
CANDELILLA WAX	WL0328HX19	IACT
CARNAUBA WAX	R12CBM0EIZ	IACT
SHEA BUTTER	K49155WL9Y	IACT
COCOA BUTTER	512OYT1CRR	IACT
AMMONIUM GLYCYRRHIZATE	3VRD35U26C	IACT
POLYHYDROXYSTEARIC ACID (2300 MW)	YXH47AOU0F	IACT
SOYBEAN OIL	241ATL177A	IACT
TOCOPHEROL	R0ZB2556P8	IACT
TRIETHOXYCAPRYLYLSILANE	LDC331P08E	IACT
EVENING PRIMROSE OIL	3Q9L08K71N	IACT
ALLANTOIN	344S277G0Z	IACT
ECHINACEA PURPUREA	QI7G114Y98	IACT
CALENDULA OFFICINALIS FLOWER	P0M7O4Y7YD	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
Aloe Vera Leaf	ZY81Z83H0X	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	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 2 · 116 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
ALLANTOIN	ALLANTOIN	344S277G0Z	GEL / TOPICAL		8 mg	Exact identifier — unii candidate
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
OLIVE OIL	OLIVE OIL	6UYK2W1W1E	SOAP / TOPICAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CAPSULE, EXTENDED RELEASE / ORAL	0.03 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
SOYBEAN OIL	SOYBEAN OIL	241ATL177A	CAPSULE / ORAL		1318 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, EXTENDED RELEASE / ORAL		2150 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	3.6 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 16 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	TABLET / ORAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	CAPSULE, COATED / ORAL	0.25 mg		Exact identifier — unii candidate 5 equally ranked IID candidates
OLIVE OIL	OLIVE OIL	6UYK2W1W1E	LOTION / TOPICAL		32468 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	TABLET / ORAL	0.08 mg		Exact identifier — unii candidate 5 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	CREAM / TOPICAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	CAPSULE, DELAYED RELEASE / ORAL		14 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
CANDELILLA WAX	CANDELILLA WAX	WL0328HX19	TABLET, FILM COATED / ORAL	0.8 mg		Exact identifier — unii candidate 4 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	POWDER, FOR SUSPENSION / ORAL		1 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, EXTENDED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
CANDELILLA WAX	CANDELILLA WAX	WL0328HX19	TABLET / ORAL		4 mg	Exact identifier — unii candidate 4 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
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SUPPOSITORY / RECTAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
SOYBEAN OIL	SOYBEAN OIL	241ATL177A	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	10 %w/v		Exact identifier — unii candidate 7 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	INJECTION / INTRAMUSCULAR		885 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	OINTMENT / TOPICAL		57 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
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, DELAYED RELEASE / ORAL		37 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, FILM COATED / ORAL		1 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	GRANULE, FOR SUSPENSION / ORAL		128 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET / SUBLINGUAL	0.13 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
OLIVE OIL	OLIVE OIL	6UYK2W1W1E	CAPSULE / ORAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION / INTRAVENOUS	NA		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
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	OINTMENT / TOPICAL	14.9 %w/w		Exact identifier — unii candidate 16 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION / ORAL		14 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET / BUCCAL	0.4 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
SOYBEAN OIL	SOYBEAN OIL	241ATL177A	INJECTION, EMULSION / INTRAVENOUS		107100 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	AEROSOL, FOAM / TOPICAL		4 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	TABLET, EXTENDED RELEASE / ORAL	23.27 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	DROPS / ORAL	NA		Exact identifier — unii candidate 21 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
SHEA BUTTER	SHEA BUTTER	K49155WL9Y	LOTION / TOPICAL		2340 mg	Exact identifier — unii candidate
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION, SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
SOYBEAN OIL	SOYBEAN OIL	241ATL177A	SOLUTION / TOPICAL	5.82 %w/w		Exact identifier — unii candidate 7 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	LOTION / TOPICAL		1000 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, DELAYED RELEASE / ORAL	230 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	CAPSULE / ORAL	1.04 mg		Exact identifier — unii candidate 16 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
CASTOR OIL	CASTOR OIL	D5340Y2I9G	CAPSULE, EXTENDED RELEASE / ORAL		47 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	TABLET / SUBLINGUAL	1.6 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	CAPSULE, COATED / ORAL	0.12 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	CREAM / TOPICAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CAPSULE / ORAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	CAPSULE, EXTENDED RELEASE / ORAL		5 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	0.15 mg		Exact identifier — unii candidate 21 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
06100db1-4158-4b92-9413-d29cec8dcc13			0f2b43ae-a05b-44d6-b002-ac78fead5d83	2013-09-17	Warnings	Exact identifier spl id: 06100db1-4158-4b92-9413-d29cec8dcc13 spl set id: 0f2b43ae-a05b-44d6-b002-ac78fead5d83

Reported adverse events (FAERS/openFDA)#

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