GAP favorite Lip Balm

Manufacturer: Autumn Harp, Inc
Effective date: 2011-12-06
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:50:14

Label at a glance#

ProductGAP favorite Lip Balm Green Apple SPF 18

Active ingredientOCTINOXATE, OXYBENZONE

Label structure10 sections

Dosage and administration

apply liberally before sun exposure and as needed children under 6 months of age: ask a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

Octinoxate 7.5% Sunscreen

Oxybenzone 6% Sunscreen

Purpose

OTC - PURPOSE SECTION

lip moisturizer
helps prevent sunburn
higher SPF gives more sunburn protection

Warning

WARNINGS SECTION

Warnings

For external use only.

When using this product

OTC - WHEN USING SECTION

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

Stop use

OTC - STOP USE SECTION

Stop use and ask doctor if rash and irritation develops and lasts

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

apply liberally before sun exposure and as needed
children under 6 months of age: ask a doctor

Sun Alert

GENERAL PRECAUTIONS SECTION

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risk of skin cancer, and other harmful effects of the sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Hydrogenated Coconut Oil, Beeswax, Euphorbia Cerifera (Candelilla) Wax, Flavor, Olea Europaea (Olive) Fruit Oil, Tocopheryl Acetate, Ammonium Glycyrrhizate, Glycine Soja (Soybean) Oil, Calendula Officinalis Flower Extract, Echinacea Purpurea Extract, Tocopherol, Lecithin, Rosmarinus Officinalis (Rosemary) Leaf Extract.

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

R04538 label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51514-0223-1	2019-11-13	C162847	48780-1	97449f38-d27d-f6ea-e053-dbdaa90aa703	Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51514-0223	GAP FAVORITE LIP BALM GREEN APPLE SPF 18 (OCTINOXATE AND OXYBENZONE) STICK [AUTUMN HARP, INC]	1	Legacy NDC	20111207_7533e26d-463b-4eae-bcab-9576d7200dfb.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	1
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	1
AMMONIUM GLYCYRRHIZATE	INACTIVE INGREDIENT	3VRD35U26C	1
CALENDULA OFFICINALIS FLOWER	INACTIVE INGREDIENT	P0M7O4Y7YD	1
CANDELILLA WAX	INACTIVE INGREDIENT	WL0328HX19	1
ECHINACEA, UNSPECIFIED	INACTIVE INGREDIENT	4N9P6CC1DX	1
OLIVE OIL	INACTIVE INGREDIENT	6UYK2W1W1E	1
ROSEMARY	INACTIVE INGREDIENT	IJ67X351P9	1
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	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 · 13 matching rows.

GAP favorite Lip Balm Green Apple SPF 18
Octinoxate and Oxybenzone
OCTINOXATE
OXYBENZONE
OLIVE OIL
YELLOW WAX
CANDELILLA WAX
CALENDULA OFFICINALIS FLOWER
TOCOPHEROL
ALPHA-TOCOPHEROL ACETATE
ROSEMARY
ECHINACEA, UNSPECIFIED
AMMONIUM GLYCYRRHIZATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51514-0223	51514-0223-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OCTINOXATE	4Y5P7MUD51	ACTIB
OXYBENZONE	95OOS7VE0Y	ACTIB
OLIVE OIL	6UYK2W1W1E	IACT
YELLOW WAX	2ZA36H0S2V	IACT
CANDELILLA WAX	WL0328HX19	IACT
CALENDULA OFFICINALIS FLOWER	P0M7O4Y7YD	IACT
TOCOPHEROL	R0ZB2556P8	IACT
ALPHA-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
ROSEMARY	IJ67X351P9	IACT
ECHINACEA, UNSPECIFIED	4N9P6CC1DX	IACT
AMMONIUM GLYCYRRHIZATE	3VRD35U26C	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 1 · 26 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, DELAYED RELEASE / ORAL	0.1 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	CAPSULE / ORAL		44 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	INJECTION, EMULSION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 5 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 3 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
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	OINTMENT / TOPICAL	20 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET / ORAL	3.22 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
OLIVE OIL	OLIVE OIL	6UYK2W1W1E	SOLUTION / TOPICAL	0.6 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
OLIVE OIL	OLIVE OIL	6UYK2W1W1E	CAPSULE / ORAL	NA		Exact identifier — unii candidate 5 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
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	CREAM / TOPICAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
CANDELILLA WAX	CANDELILLA WAX	WL0328HX19	TABLET, EXTENDED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 4 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, DELAYED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
OLIVE OIL	OLIVE OIL	6UYK2W1W1E	SOAP / TOPICAL	NA		Exact identifier — unii candidate 5 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
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	TABLET / ORAL	0.08 mg		Exact identifier — unii candidate 5 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
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, COATED / ORAL	213.7 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
OLIVE OIL	OLIVE OIL	6UYK2W1W1E	SOLUTION / ORAL	425 mg/1ml		Exact identifier — unii candidate 5 equally ranked IID candidates
CANDELILLA WAX	CANDELILLA WAX	WL0328HX19	TABLET / ORAL		4 mg	Exact identifier — unii candidate 4 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	CAPSULE, COATED / ORAL	0.25 mg		Exact identifier — unii candidate 5 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	CAPSULE / ORAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	CREAM / TOPICAL	5 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 9 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
bc21e31a-3343-4126-ae58-401327739921			7533e26d-463b-4eae-bcab-9576d7200dfb	2011-12-06	Warnings	Exact identifier spl id: bc21e31a-3343-4126-ae58-401327739921 spl set id: 7533e26d-463b-4eae-bcab-9576d7200dfb

Reported adverse events (FAERS/openFDA)#

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