Inspired by Color

Manufacturer
GANZ U.S.A., LLC
Effective date
2011-04-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:27:52

Label at a glance#

ProductSun-Kissed Lip Balm Lemon Lime SPF30
Active ingredientOCTINOXATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE
Label structure8 sections

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

PRINCIPAL DISPLAY PANEL - 4 g Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

time & again®

SPF30
UVA/UVB SUNSCREEN PROTECTION

LIP BALM

Net wt 4 g (0.14 Oz)

Principal Display Panel - 4 g Box
Principal Display Panel - 4 g Box

PRINCIPAL DISPLAY PANEL - 4 g Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

time & again®

SPF30
UVA/UVB SUNSCREEN PROTECTION

LIP BALM

Net wt 4 g (0.14 Oz)

Principal Display Panel - 4 g Box
Principal Display Panel - 4 g Box

PRINCIPAL DISPLAY PANEL - 4 g Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LIP BALM
with SPF30

UVA/UVB Sunscreen Protection

Lemon Lime

Principal Display Panel - 4 g Box
Principal Display Panel - 4 g Box

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75862-015-502019-10-29C16284748780-1960f7f55-ce9f-8e05-e053-dbdaa90a074aLemon-Lime Lip Balm
75862-016-502019-10-29C16284748780-1960f7f55-ce9f-8e05-e053-dbdaa90a074aLemon-Lime Lip Balm
75862-017-502019-10-29C16284748780-1960f7f55-ce9f-8e05-e053-dbdaa90a074aLemon-Lime Lip Balm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75862-015-50Sun-Kissed Lip Balm Lemon Lime SPF304 g in 1 TUBESTICK41
75862-015-50Sun-Kissed Lip Balm Lemon Lime SPF301 in 1 BOXSTICK11
75862-016-50Kiss and Shield Lip Balm Lemon Lime SPF 301 in 1 BOXSTICK11
75862-016-50Kiss and Shield Lip Balm Lemon Lime SPF 304 g in 1 TUBESTICK41
75862-017-50Inspired by Color Lemon Lime SPF 301 in 1 BOXSTICK11
75862-017-50Inspired by Color Lemon Lime SPF 304 g in 1 TUBESTICK41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75862-015SUN-KISSED LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK KISS AND SHIELD LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK INSPIRED BY COLOR (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [GANZ U.S.A., LLC]1Legacy NDC, 2 package rows20110428_ff3d2e5a-95ae-4e15-99d4-9ddbd0a72e53.zip
75862-016SUN-KISSED LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK KISS AND SHIELD LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK INSPIRED BY COLOR (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [GANZ U.S.A., LLC]1Legacy NDC, 2 package rows20110428_ff3d2e5a-95ae-4e15-99d4-9ddbd0a72e53.zip
75862-017SUN-KISSED LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK KISS AND SHIELD LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK INSPIRED BY COLOR (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [GANZ U.S.A., LLC]1Legacy NDC, 2 package rows20110428_ff3d2e5a-95ae-4e15-99d4-9ddbd0a72e53.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OCTISALATEACTIVE MOIETY4X49Y0596W1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM1
OXYBENZONEACTIVE MOIETY95OOS7VE0Y1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX191
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJS1
LANOLININACTIVE INGREDIENT7EV65EAW6H1
LOW DENSITY POLYETHYLENEINACTIVE INGREDIENTJ245LN42AI1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
OCTYLDODECANOLINACTIVE INGREDIENT461N1O614Y1
OLEYL ALCOHOLINACTIVE INGREDIENT172F2WN8DV1
PARAFFININACTIVE INGREDIENTI9O0E3H2ZE1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U1
PHENYL TRIMETHICONEINACTIVE INGREDIENTDR0K5NOJ4R1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
SACCHARININACTIVE INGREDIENTFST467XS7D1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
SOYBEAN OILINACTIVE INGREDIENT241ATL177A1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75862-01575862-015-50
75862-01675862-016-50
75862-01775862-017-50

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 66 matching rows.

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 ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii candidate
18 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
3 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR0.4 mgExact identifier — unii candidate
68 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSOINTMENT / TOPICAL35 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / TOPICAL24 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHPASTE, DENTIFRICE / DENTALNAExact identifier — unii candidate
68 equally ranked IID candidates
SACCHARINSACCHARINFST467XS7DSUSPENSION / ORAL12.5 mg/5mlExact identifier — unii candidate
16 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii candidate
20 equally ranked IID candidates
OLEYL ALCOHOLOLEYL ALCOHOL172F2WN8DVGEL / TRANSDERMAL1.5 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177AINJECTION, EMULSION / INTRAVENOUS107100 mgExact identifier — unii candidate
7 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, LIQUID FILLED / ORAL12 mgExact identifier — unii candidate
40 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRAMUSCULAR95 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHGEL / TOPICAL4 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TDROPS / NASAL26 mgExact identifier — unii candidate
79 equally ranked IID candidates
SACCHARINSACCHARINFST467XS7DAEROSOL, METERED / RESPIRATORY (INHALATION)0.05 %w/wExact identifier — unii candidate
16 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET, CHEWABLE / ORAL1.28 mgExact identifier — unii candidate
79 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, EXTENDED RELEASE / ORAL90 mgExact identifier — unii candidate
40 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UTABLET / ORAL3.5 mgExact identifier — unii candidate
18 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET / ORAL1.8 mgExact identifier — unii candidate
79 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4DROPS / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUPPOSITORY / VAGINALNAExact identifier — unii candidate
68 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TAMPON / VAGINALNAExact identifier — unii candidate
49 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT, AUGMENTED / TOPICAL81.94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUPPOSITORY / VAGINALNAExact identifier — unii candidate
79 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSUSPENSION / ORAL113 mgExact identifier — unii candidate
40 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / EPIDURAL30 mgExact identifier — unii candidate
79 equally ranked IID candidates
CANDELILLA WAXCANDELILLA WAXWL0328HX19TABLET / ORAL4 mgExact identifier — unii candidate
4 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZEOINTMENT / TOPICAL2860 mgExact identifier — unii candidate
11 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TFILM / BUCCAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED / ORAL3 mgExact identifier — unii candidate
49 equally ranked IID candidates
OCTYLDODECANOLOCTYLDODECANOL461N1O614YCREAM / TOPICAL160 mgExact identifier — unii candidate
9 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHELIXIR / ORAL200 mgExact identifier — unii candidate
68 equally ranked IID candidates
OCTYLDODECANOLOCTYLDODECANOL461N1O614YCREAM / VAGINAL13.5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCONCENTRATE / ORAL2.5 mg/5mlExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / NASAL250 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCAPSULE / ORAL7 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii candidate
68 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, COATED / ORAL0.25 mgExact identifier — unii candidate
20 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZEAEROSOL, FOAM / TOPICAL14235 mgExact identifier — unii candidate
11 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / SUBCUTANEOUS2 mgExact identifier — unii candidate
68 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSLOTION / TOPICAL50 mgExact identifier — unii candidate
18 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
79 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, FILM COATED / ORALNAExact identifier — unii candidate
20 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / ORAL100 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHDROPS / NASAL14 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / INTRAMUSCULAR0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / RECTAL105 mgExact identifier — unii candidate
9 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / INTRAMUSCULAR45 mgExact identifier — unii candidate
79 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / OPHTHALMIC3 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TOINTMENT / TOPICAL29 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSYSTEM / TOPICAL21 mgExact identifier — unii candidate
68 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING / ORAL68 mgExact identifier — unii candidate
49 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / ORAL388 mgExact identifier — unii candidate
79 equally ranked IID candidates
OCTYLDODECANOLOCTYLDODECANOL461N1O614YGEL / TOPICAL10 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPINSERT, EXTENDED RELEASE / OPHTHALMIC0.4 mgExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
40 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
79 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
7520e137-ca8e-4dcd-af38-79a2f74a6175ff3d2e5a-95ae-4e15-99d4-9ddbd0a72e532011-04-25WarningsExact identifier
spl id: 7520e137-ca8e-4dcd-af38-79a2f74a6175
spl set id: ff3d2e5a-95ae-4e15-99d4-9ddbd0a72e53

Reported adverse events (FAERS/openFDA)#

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