Hydrating Lip Balm SPF 15 sunscreen

Manufacturer: AUSTRALIAN SKIN PRODUCTS PTY LTD | Natural Beauty Care Pty Ltd
Effective date: 2014-08-07
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:40:03

Label at a glance#

ProductHydrating Lip Balm SPF 15 sunscreen ASAP

Active ingredientAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE

Label structure2 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose

Avobenzone 3.5% Sunscreen

Homosalate 5.0% Sunscreen

Octocrylene 5.0% Sunscreen

Octisalate 5.0% Sunscreen

OTC - PURPOSE SECTION

Uses: Helps prevent sunburn and chapped lips. 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.

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.

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs.

WARNINGS SECTION

Warnings:

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

DOSAGE & ADMINISTRATION SECTION

Directions

Apply Liberally to lips as often as desired

Apply liberally 15 minutes before sun exposure

Reapply: at least every 2 hours

Use a water resistant sunscreen if swimming or sweating

Sun Protectection 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 15 or higher and other skin protection measures including:

- Limit time in the sun especially from 10 a.m. -2 p.m.

- Wear long-sleeve shirts, pants, and sunglasses

- Children under 6 months ask a doctor

INACTIVE INGREDIENT SECTION

Hydrogenated Polysiobutene, Ethylene/Propylene/Styrene Copolymer, Nicinamide, Rohododendron Ferruineum (Alpine Rose) Extract, Tricaprylin, Polyamide-3, Ethyl Macadamiate, Bisabolol, Tocopherol, Zingiber Officinale (Ginger) Root Extract, Glycerin, Malic Acid, Citrus Reticulata (Tangerine) Peel Oil, Citrus Paradisi (Grapefruit) Peel Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Medica Limonium (Lemon) peel Oil, Ethyl Methylphenylglycidate, Butylene/Ethylene/Styrene Copolymer, BHT,limonene.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

asap

the science of beautiful

hydrating lip balm+

with niacinamide +Alpine Rose
protect

SPF 15 SUNSCREEN

10mL/0.34floz

Box

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76261-127-02	2019-11-27	C162847	48780-1	9855e2a2-3e31-60a7-e053-dbdaa90a05bd	hydrating lip balm SPF 15 Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76261-127-01	Hydrating Lip Balm SPF 15 sunscreenASAP	10 mL in 1 TUBE	GEL	10		1
76261-127-02	Hydrating Lip Balm SPF 15 sunscreenASAP	1 in 1 CARTON	GEL	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76261-127	HYDRATING LIP BALM SPF 15 SUNSCREEN ASAP (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) GEL [AUSTRALIAN SKIN PRODUCTS PTY LTD]	1	Legacy NDC, 2 package rows	20140821_bafadc36-5019-4f18-a4fd-85f8d4a70053.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	1
HOMOSALATE	ACTIVE INGREDIENT	V06SV4M95S	1
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	1
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	1
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	1
HOMOSALATE	ACTIVE MOIETY	V06SV4M95S	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	1
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	1
.ALPHA.-BISABOLOL, (+)-	INACTIVE INGREDIENT	105S6I733Z	1
BERGAMOT OIL	INACTIVE INGREDIENT	39W1PKE3JI	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	1
ETHYL MACADAMIATE	INACTIVE INGREDIENT	ANA2NCS6V1	1
ETHYL METHYLPHENYLGLYCIDATE	INACTIVE INGREDIENT	UD51D5KR4A	1
GINGER	INACTIVE INGREDIENT	C5529G5JPQ	1
GRAPEFRUIT OIL	INACTIVE INGREDIENT	YR377U58W9	1
HYDROGENATED POLYBUTENE (1300 MW)	INACTIVE INGREDIENT	7D1YQ9Y5EZ	1
LEMON OIL	INACTIVE INGREDIENT	I9GRO824LL	1
LIMONENE, (+)-	INACTIVE INGREDIENT	GFD7C86Q1W	1
MALIC ACID	INACTIVE INGREDIENT	817L1N4CKP	1
MANDARIN OIL	INACTIVE INGREDIENT	NJO720F72R	1
NIACINAMIDE	INACTIVE INGREDIENT	25X51I8RD4	1
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	1
TRICAPRYLIN	INACTIVE INGREDIENT	6P92858988	1

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

Hydrating Lip Balm SPF 15 sunscreen ASAP
Avobenzone, Homosalate, Octocrylene, Octisalate
AVOBENZONE
HOMOSALATE
OCTOCRYLENE
OCTISALATE
HYDROGENATED POLYBUTENE (1300 MW)
NIACINAMIDE
TRICAPRYLIN
ETHYL MACADAMIATE
.ALPHA.-BISABOLOL, (+)-
TOCOPHEROL
GINGER
MALIC ACID
MANDARIN OIL
GRAPEFRUIT OIL
BERGAMOT OIL
LEMON OIL
ETHYL METHYLPHENYLGLYCIDATE
BUTYLATED HYDROXYTOLUENE
LIMONENE, (+)-

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
76261-127	76261-127-01, 76261-127-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
AVOBENZONE	G63QQF2NOX	ACTIB
HOMOSALATE	V06SV4M95S	ACTIB
OCTOCRYLENE	5A68WGF6WM	ACTIB
OCTISALATE	4X49Y0596W	ACTIB
HYDROGENATED POLYBUTENE (1300 MW)	7D1YQ9Y5EZ	IACT
NIACINAMIDE	25X51I8RD4	IACT
TRICAPRYLIN	6P92858988	IACT
ETHYL MACADAMIATE	ANA2NCS6V1	IACT
.ALPHA.-BISABOLOL, (+)-	105S6I733Z	IACT
TOCOPHEROL	R0ZB2556P8	IACT
GINGER	C5529G5JPQ	IACT
MALIC ACID	817L1N4CKP	IACT
MANDARIN OIL	NJO720F72R	IACT
GRAPEFRUIT OIL	YR377U58W9	IACT
BERGAMOT OIL	39W1PKE3JI	IACT
LEMON OIL	I9GRO824LL	IACT
ETHYL METHYLPHENYLGLYCIDATE	UD51D5KR4A	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT
LIMONENE, (+)-	GFD7C86Q1W	IACT

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 · 57 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
LEMON OIL	LEMON OIL, COLD PRESSED	I9GRO824LL	PASTE, DENTIFRICE / DENTAL	0.7 %w/w		Exact identifier — unii candidate 4 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CAPSULE, LIQUID FILLED / ORAL	0.1 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	CREAM / TOPICAL	NA		Exact identifier — unii candidate 5 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	SOAP / TOPICAL	0.02 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
LEMON OIL	LEMON OIL, COLD PRESSED	I9GRO824LL	CAPSULE / ORAL	8.5 mg		Exact identifier — unii candidate 4 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SHAMPOO / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
TRICAPRYLIN	TRICAPRILIN	6P92858988	INJECTION, SUSPENSION, LIPOSOMAL / EPIDURAL		1 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
NIACINAMIDE	NIACINAMIDE	25X51I8RD4	CREAM / TOPICAL	NA		Exact identifier — unii candidate 4 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
LIMONENE, (+)-	LIMONENE, (+)-	GFD7C86Q1W	LOTION / TOPICAL	10 %v/v		Exact identifier — unii candidate 3 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION, SOLUTION / INTRAVENOUS	NA		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
TRICAPRYLIN	TRICAPRILIN	6P92858988	INJECTABLE, LIPOSOMAL / INFILTRATION	0.2 %w/v		Exact identifier — unii candidate 2 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	AEROSOL, FOAM / TOPICAL		4 mg	Exact identifier — unii candidate 32 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
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION / TOPICAL		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
LIMONENE, (+)-	LIMONENE, (+)-	GFD7C86Q1W	GEL / TOPICAL		10 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SUPPOSITORY / RECTAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM / TOPICAL		6 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION / ORAL		14 mg	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
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
LEMON OIL	LEMON OIL, COLD PRESSED	I9GRO824LL	SUSPENSION / ORAL		1 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET, ORALLY DISINTEGRATING / ORAL		1 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
NIACINAMIDE	NIACINAMIDE	25X51I8RD4	INJECTION / INTRAMUSCULAR	2.5 %w/v		Exact identifier — unii candidate 4 equally ranked IID candidates
MALIC ACID	MALIC ACID	817L1N4CKP	POWDER, FOR SOLUTION / ORAL		1230 mg	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
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM / VAGINAL	0.05 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
LIMONENE, (+)-	LIMONENE, (+)-	GFD7C86Q1W	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
NIACINAMIDE	NIACINAMIDE	25X51I8RD4	GEL / TOPICAL		25 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	LOTION / TOPICAL		1000 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET, FOR SUSPENSION / ORAL	0.1 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	TABLET / ORAL	0.08 mg		Exact identifier — unii candidate 5 equally ranked IID candidates
MALIC ACID	MALIC ACID	817L1N4CKP	SUSPENSION / ORAL		180 mg	Exact identifier — unii candidate 5 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	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	0.02 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GUM, CHEWING / BUCCAL		5 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
NIACINAMIDE	NIACINAMIDE	25X51I8RD4	INJECTION / INTRAVENOUS	2.5 %w/v		Exact identifier — unii candidate 4 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET / SUBLINGUAL	0.13 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	OINTMENT / TOPICAL		57 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM, AUGMENTED / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
MALIC ACID	MALIC ACID	817L1N4CKP	TABLET / ORAL		20 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
MALIC ACID	MALIC ACID	817L1N4CKP	POWDER, FOR SUSPENSION / ORAL		1392 mg	Exact identifier — unii candidate 5 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
LEMON OIL	LEMON OIL, COLD PRESSED	I9GRO824LL	GEL / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 4 equally ranked IID candidates
GINGER	GINGER	C5529G5JPQ	ELIXIR / ORAL	10 mg/5ml		Exact identifier — unii candidate 2 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CAPSULE / ORAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION / INTRAVENOUS	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	INJECTION, EMULSION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 5 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	CAPSULE / ORAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GEL, METERED / TOPICAL		4 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
GINGER	GINGER	C5529G5JPQ	SYRUP / ORAL	0.05 ml/5ml		Exact identifier — unii candidate 2 equally ranked IID candidates
MALIC ACID	MALIC ACID	817L1N4CKP	SOLUTION / ORAL		16760 mg	Exact identifier — unii candidate 5 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
76039001-5295-415d-9010-930f5019b7a7			bafadc36-5019-4f18-a4fd-85f8d4a70053	2014-08-07	Warnings	Exact identifier spl id: 76039001-5295-415d-9010-930f5019b7a7 spl set id: bafadc36-5019-4f18-a4fd-85f8d4a70053

Reported adverse events (FAERS/openFDA)#

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