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Sun Bum Sunscreen Lip Balms Broad Spectrum SPF 30 - Banana, Coconut, Watermelon

Sun Bum Sunscreen Lip Balm Broad Spectrum SPF 30 - Coconut; Muti Pack - Banana, Coconut, Watermelon

Approved
Approval ID

3d37ec29-8d15-c716-e063-6394a90ae709

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 25, 2025

Manufacturers
FDA

Sun Bum, LLC

DUNS: 028642574

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69039-827
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 25, 2025
FDA Product Classification

INGREDIENTS (38)

AVOBENZONEActive
Quantity: 30 mg in 1 g
Code: G63QQF2NOX
Classification: ACTIB
OCTISALATEActive
Quantity: 50 mg in 1 g
Code: 4X49Y0596W
Classification: ACTIB
HYDROGENATED OLIVE OIL UNSAPONIFIABLESInactive
Code: B8MIX97W95
Classification: IACT
MACROCYSTIS PYRIFERA (KELP)Inactive
Code: K31S3OG5C4
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEInactive
Code: C9H2L21V7U
Classification: IACT
GRAPEFRUITInactive
Code: O82C39RR8C
Classification: IACT
CERESINInactive
Code: Q1LS2UJO3A
Classification: IACT
PANAX GINSENG ROOTInactive
Code: CUQ3A77YXI
Classification: IACT
WILLOW BARKInactive
Code: S883J9JDYX
Classification: IACT
SAGEInactive
Code: 065C5D077J
Classification: IACT
.ALPHA.-TOCOPHEROL LINOLEATE, D-Inactive
Code: G0N132Q0ED
Classification: IACT
DIISOBUTYL ADIPATEInactive
Code: 8OPY05ZY7S
Classification: IACT
HYDROGENATED ETHYLHEXYL OLIVATEInactive
Code: JBH5K4WD8L
Classification: IACT
PUNICA GRANATUM WHOLEInactive
Code: O2ZTS50U5E
Classification: IACT
SILICAInactive
Code: ETJ7Z6XBU4
Classification: IACT
EQUISETUM ARVENSE WHOLEInactive
Code: 73DM367W4P
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SACCHARINInactive
Code: FST467XS7D
Classification: IACT
HOMOSALATEActive
Quantity: 100 mg in 1 g
Code: V06SV4M95S
Classification: ACTIB
BISABOLOLInactive
Code: 24WE03BX2T
Classification: IACT
THEOBROMA CACAO (COCOA) SEED BUTTERInactive
Code: 512OYT1CRR
Classification: IACT
PEG-8Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
CUCUMIS SATIVUS (CUCUMBER) FRUITInactive
Code: YY7C30VXJT
Classification: IACT
ROSMARINUS OFFICINALIS WHOLEInactive
Code: EA3289138M
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
CALENDULA OFFICINALIS FLOWERInactive
Code: P0M7O4Y7YD
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
ALOE BARBADENSIS LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
CAMELLIA SINENSIS LEAFInactive
Code: W2ZU1RY8B0
Classification: IACT
OCTOCRYLENEActive
Quantity: 80 mg in 1 g
Code: 5A68WGF6WM
Classification: ACTIB
ARGANIA SPINOSA KERNEL OILInactive
Code: 4V59G5UW9X
Classification: IACT
LEMON PEELInactive
Code: 72O054U628
Classification: IACT
ETHYLHEXYL PALMITATEInactive
Code: 2865993309
Classification: IACT
GINKGO BILOBA LEAFInactive
Code: 19FUJ2C58T
Classification: IACT
ISOSTEARYL LINOLEATEInactive
Code: 4778M3HR0N
Classification: IACT

AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69039-823
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 25, 2025
FDA Product Classification

INGREDIENTS (38)

AVOBENZONEActive
Quantity: 30 mg in 1 g
Code: G63QQF2NOX
Classification: ACTIB
OCTISALATEActive
Quantity: 50 mg in 1 g
Code: 4X49Y0596W
Classification: ACTIB
HYDROGENATED OLIVE OIL UNSAPONIFIABLESInactive
Code: B8MIX97W95
Classification: IACT
MACROCYSTIS PYRIFERA (KELP)Inactive
Code: K31S3OG5C4
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEInactive
Code: C9H2L21V7U
Classification: IACT
GRAPEFRUITInactive
Code: O82C39RR8C
Classification: IACT
CERESINInactive
Code: Q1LS2UJO3A
Classification: IACT
PANAX GINSENG ROOTInactive
Code: CUQ3A77YXI
Classification: IACT
WILLOW BARKInactive
Code: S883J9JDYX
Classification: IACT
SAGEInactive
Code: 065C5D077J
Classification: IACT
.ALPHA.-TOCOPHEROL LINOLEATE, D-Inactive
Code: G0N132Q0ED
Classification: IACT
HOMOSALATEActive
Quantity: 100 mg in 1 g
Code: V06SV4M95S
Classification: ACTIB
BISABOLOLInactive
Code: 24WE03BX2T
Classification: IACT
THEOBROMA CACAO (COCOA) SEED BUTTERInactive
Code: 512OYT1CRR
Classification: IACT
ALOE BARBADENSIS LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
GINKGO BILOBA LEAFInactive
Code: 19FUJ2C58T
Classification: IACT
CALENDULA OFFICINALIS FLOWERInactive
Code: P0M7O4Y7YD
Classification: IACT
DIISOBUTYL ADIPATEInactive
Code: 8OPY05ZY7S
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CAMELLIA SINENSIS LEAFInactive
Code: W2ZU1RY8B0
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
HYDROGENATED ETHYLHEXYL OLIVATEInactive
Code: JBH5K4WD8L
Classification: IACT
PUNICA GRANATUM WHOLEInactive
Code: O2ZTS50U5E
Classification: IACT
SILICAInactive
Code: ETJ7Z6XBU4
Classification: IACT
EQUISETUM ARVENSE WHOLEInactive
Code: 73DM367W4P
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SACCHARINInactive
Code: FST467XS7D
Classification: IACT
OCTOCRYLENEActive
Quantity: 80 mg in 1 g
Code: 5A68WGF6WM
Classification: ACTIB
ARGANIA SPINOSA KERNEL OILInactive
Code: 4V59G5UW9X
Classification: IACT
LEMON PEELInactive
Code: 72O054U628
Classification: IACT
ETHYLHEXYL PALMITATEInactive
Code: 2865993309
Classification: IACT
ISOSTEARYL LINOLEATEInactive
Code: 4778M3HR0N
Classification: IACT
PEG-8Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
ROSMARINUS OFFICINALIS WHOLEInactive
Code: EA3289138M
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
CUCUMIS SATIVUS (CUCUMBER) FRUITInactive
Code: YY7C30VXJT
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/1/2025

Sun Bum Sunscreen Lip Balms Broad Spectrum SPF 30 - Banana, Coconut,

Watermelon Primary Artwork

Primary Artwork

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/1/2025

Uses

• helps prevent sunburn • 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

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 1/1/2025

Other Information

protect this product from excessive heat and direct sun

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 1/1/2025

Active Ingredients

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 8%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 1/1/2025

Purpose

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 1/1/2025

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.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 1/1/2025

Warnings

Keep Out Of Reach Of Children

INSTRUCTIONS FOR USE SECTION

LOINC: 59845-8Updated: 1/1/2025

Directions

• apply liberally 15 minutes before sun exposure

• reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours

• children under 6 months of age: ask a doctor

• Sun Protection 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 value of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10 a.m.- 2 p.m.

• wear long-sleeved shirts, pants, hats and sunglasses

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/1/2025

Directions

• apply liberally 15 minutes before sun exposure

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/1/2025

Inactive Ingredients

aloe barbadensis leaf extract, argania spinosa kernel oil, bisabolol, camellia sinensis leaf extract, caprylic/capric triglyceride, calendula officinalis flower extract, cetyl alcohol, citrus grandis fruit extract, citrus limon peel extract, cucumis sativus (cucumber) fruit extract, diisobutyl adipate, equisetum arvense extract, ethylhexyl palmitate, fragrance, ginkgo biloba leaf extract, hydrogenated ethylhexyl olivate, hydrogenated olive oil unsaponifiables, isostearyl linoleate, macrocystis pyrifera extract, mineral oil, ozokerite, panax ginseng root extract, PEG-8, polysorbate 80, propylene glycol, punica granatum extract, rosmarinus officinalis extract, saccharin, salix alba (willow) bark extract, salvia officinalis (sage) extract, silica, theobroma cacao seed butter, tocopheryl acetate, tocopheryl linoleate/oleate, water

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 1/1/2025

Questions?

1-877-978-6286

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