FOR THE GARDENER LIP BALM

Manufacturer: GANZ U.S.A., LLC
Effective date: 2011-08-16
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:29:16

Label at a glance#

ProductFOR THE GARDENER LIP BALM SPF 30

Active ingredientOCTINOXATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE

Label structure8 sections

Storage and handling

You may report serious adverse reaction to this product to: Ganz U.S.A., LLC #043, 60 Industrial Parkway, Cheektowaga, New York, 14227-9903

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%, Octocrylene 7.0%, Octisalate 5.0%, Oxybenzone 5.0%

Purposes

OTC - PURPOSE SECTION

Sunscreens

Use

INDICATIONS & USAGE SECTION

helps prevent sunburn

Warnings

WARNINGS SECTION

OTC - STOP USE SECTION

Stop use if skin rash occurs

Inactive ingredients

INACTIVE INGREDIENT SECTION

petrolatum, isopropyl myristate, paraffin, candelilla wax, synthetic beeswax, polyethylene, cetyl alcohol, lanolin, isopropyl lanolate, oleyl alcohol, octyldodecanol, phenyl trimethicone, flavor, tocopheryl acetate, aloe barbadensis leaf extract, glycine soja (soybean) oil, titanium dioxide, methylparaben, propylparaben, silica, saccharin, DEA-oleth-3-phosphate

Other information

STORAGE AND HANDLING SECTION

You may report serious adverse reaction to this product to: Ganz U.S.A., LLC #043, 60 Industrial Parkway, Cheektowaga, New York, 14227-9903

SPL UNCLASSIFIED SECTION

MANUFACTURED FOR:
GANZ, Cheektowaga, N.Y. 14227-9903

PRINCIPAL DISPLAY PANEL - 4 g Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

time & again^®

LIP BALM

SPF 30
ALOE & VITAMIN E

UVA/UVB SUNSCREEN PROTECTION

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
baf7f49c-75b6-496b-a00e-8e766a8e4f03	Product name	1	20210127
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
75862-018-50	2019-10-29	C162847	48780-1	960f7f55-ca22-8e05-e053-dbdaa90a074a	time & again ® LIP BALM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
75862-018-50	FOR THE GARDENER LIP BALM SPF 30	4 g in 1 TUBE	STICK	4		1
75862-018-50	FOR THE GARDENER LIP BALM SPF 30	1 in 1 BOX	STICK	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75862-018	FOR THE GARDENER LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [GANZ U.S.A., LLC]	1	Legacy NDC, 2 package rows	20110819_f0d3c419-a743-4ed6-b9cf-b50812bec8f2.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
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	1
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	1
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	1
CANDELILLA WAX	INACTIVE INGREDIENT	WL0328HX19	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	1
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	1
LOW DENSITY POLYETHYLENE	INACTIVE INGREDIENT	J245LN42AI	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
OCTYLDODECANOL	INACTIVE INGREDIENT	461N1O614Y	1
OLEYL ALCOHOL	INACTIVE INGREDIENT	172F2WN8DV	1
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	1
PHENYL TRIMETHICONE	INACTIVE INGREDIENT	DR0K5NOJ4R	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1
SACCHARIN	INACTIVE INGREDIENT	FST467XS7D	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
SOYBEAN OIL	INACTIVE INGREDIENT	241ATL177A	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

FOR THE GARDENER LIP BALM SPF 30
OCTINOXATE, OCTOCRYLENE, OCTISALATE, and OXYBENZONE
OCTINOXATE
OCTOCRYLENE
OCTISALATE
OXYBENZONE
PETROLATUM
ISOPROPYL MYRISTATE
PARAFFIN
CANDELILLA WAX
LOW DENSITY POLYETHYLENE
CETYL ALCOHOL
LANOLIN
OLEYL ALCOHOL
OCTYLDODECANOL
PHENYL TRIMETHICONE
ALPHA-TOCOPHEROL ACETATE
ALOE VERA LEAF
SOYBEAN OIL
TITANIUM DIOXIDE
METHYLPARABEN
PROPYLPARABEN
SILICON DIOXIDE
SACCHARIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
75862-018	75862-018-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OCTINOXATE	4Y5P7MUD51	ACTIB
OCTOCRYLENE	5A68WGF6WM	ACTIB
OCTISALATE	4X49Y0596W	ACTIB
OXYBENZONE	95OOS7VE0Y	ACTIB
PETROLATUM	4T6H12BN9U	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
PARAFFIN	I9O0E3H2ZE	IACT
CANDELILLA WAX	WL0328HX19	IACT
LOW DENSITY POLYETHYLENE	J245LN42AI	IACT
CETYL ALCOHOL	936JST6JCN	IACT
LANOLIN	7EV65EAW6H	IACT
OLEYL ALCOHOL	172F2WN8DV	IACT
OCTYLDODECANOL	461N1O614Y	IACT
PHENYL TRIMETHICONE	DR0K5NOJ4R	IACT
ALPHA-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
SOYBEAN OIL	241ATL177A	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SACCHARIN	FST467XS7D	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 6 · 358 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	GEL / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUSPENSION / ORAL		113 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CONCENTRATE / ORAL		12 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE PARTICLES / ORAL		170 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SACCHARIN	SACCHARIN	FST467XS7D	TABLET, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
OLEYL ALCOHOL	OLEYL ALCOHOL	172F2WN8DV	SYSTEM / TRANSDERMAL	6.12 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, EXTENDED RELEASE / ORAL		90 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SACCHARIN	SACCHARIN	FST467XS7D	TABLET, CHEWABLE / ORAL	0.9 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		42 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	EMULSION / TOPICAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	CREAM / TOPICAL		1280 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION/ DROPS / OPHTHALMIC	0.01 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
SACCHARIN	SACCHARIN	FST467XS7D	SUSPENSION / ORAL	12.5 mg/5ml		Exact identifier — unii candidate 16 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SOAP / TOPICAL	1 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	GEL / VAGINAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IRRIGATION	2 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRAVENOUS		95 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	LOZENGE / ORAL		120 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / ORAL		388 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	AEROSOL, FOAM / TOPICAL	7.9 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
SOYBEAN OIL	SOYBEAN OIL	241ATL177A	INJECTION, EMULSION / INTRAVENOUS		107100 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
OLEYL ALCOHOL	OLEYL ALCOHOL	172F2WN8DV	LOTION / TOPICAL		11700 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
OCTYLDODECANOL	OCTYLDODECANOL	461N1O614Y	FILM / TRANSDERMAL	32.44 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	LOTION / TOPICAL		1140 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	TABLET, EXTENDED RELEASE / ORAL	0.18 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	EMULSION / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / TOPICAL	0.16 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SHAMPOO / TOPICAL	0.03 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CAPSULE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / TOPICAL	0.8 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 79 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
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	SPRAY / TOPICAL		3665 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / BUCCAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
SACCHARIN	SACCHARIN	FST467XS7D	GRANULE, FOR SOLUTION / ORAL		16 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	59 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SUPPOSITORY / VAGINAL	27 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	DROPS / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, EXTENDED RELEASE / ORAL		168 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	CREAM / VAGINAL	2 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION/ DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / PARENTERAL		18 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	OINTMENT / RECTAL		105 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / ORAL	100 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
OCTYLDODECANOL	OCTYLDODECANOL	461N1O614Y	SUSPENSION / TOPICAL	2.01 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET / ORAL	0.2 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / EPIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM, AUGMENTED / TOPICAL	26 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
OCTYLDODECANOL	OCTYLDODECANOL	461N1O614Y	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	ELIXIR / ORAL	800 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET / ORAL	1.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, CHEWABLE / ORAL	0.14 mg		Exact identifier — unii candidate 68 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
8eeb92ef-bf4c-436e-a70c-2538df88cb72			f0d3c419-a743-4ed6-b9cf-b50812bec8f2	2011-08-16	Warnings	Exact identifier spl id: 8eeb92ef-bf4c-436e-a70c-2538df88cb72 spl set id: f0d3c419-a743-4ed6-b9cf-b50812bec8f2

Reported adverse events (FAERS/openFDA)#

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