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Sun Bum Daily Gel Gel Sunscreen Moisturizer Broad Spectrum SPF 50

Sun Bum Daily Gel Gel Sunscreen Moisturizer Broad Spectrum SPF 50

Approved
Approval ID

15d8574d-94bb-4842-e063-6394a90a15e6

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 23, 2025

Manufacturers
FDA

Sun Bum, LLC

DUNS: 028642574

Products 1

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 Code69039-662
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 23, 2025
FDA Product Classification

INGREDIENTS (22)

NEOPENTYL GLYCOL DIHEPTANOATEInactive
Code: 5LKW3C543X
Classification: IACT
OCTISALATEActive
Quantity: 50 mg in 1 mL
Code: 4X49Y0596W
Classification: ACTIB
OCTOCRYLENEActive
Quantity: 100 mg in 1 mL
Code: 5A68WGF6WM
Classification: ACTIB
PONGAMIA PINNATA SEEDInactive
Code: C2BRV53B1V
Classification: IACT
ISODODECANEInactive
Code: A8289P68Y2
Classification: IACT
DICAPRYLYL CARBONATEInactive
Code: 609A3V1SUA
Classification: IACT
TRIDECANEInactive
Code: A3LZF0L939
Classification: IACT
TETRAHEXYLDECYL ASCORBATEInactive
Code: 9LBV3F07AZ
Classification: IACT
CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OILInactive
Code: 0QW9S92J3K
Classification: IACT
SUNFLOWER OILInactive
Code: 3W1JG795YI
Classification: IACT
UNDECANEInactive
Code: JV0QT00NUE
Classification: IACT
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
AVOBENZONEActive
Quantity: 30 mg in 1 mL
Code: G63QQF2NOX
Classification: ACTIB
HOMOSALATEActive
Quantity: 90 mg in 1 mL
Code: V06SV4M95S
Classification: ACTIB
COCONUT OILInactive
Code: Q9L0O73W7L
Classification: IACT
JOJOBA OILInactive
Code: 724GKU717M
Classification: IACT
BUTYLOCTYL SALICYLATEInactive
Code: 2EH13UN8D3
Classification: IACT
CITRONELLOL ACETATE, (S)-Inactive
Code: 78RZL4H51H
Classification: IACT
ALPHA-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
HYDRATED SILICAInactive
Code: Y6O7T4G8P9
Classification: IACT
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMERInactive
Code: O4I3UFO6ZF
Classification: IACT
POLYESTER-7Inactive
Code: 0841698D2F
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 4/15/2024

Package Image

Sun Bum Daily Gel (PDP)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 4/11/2024

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 4/15/2024

Active Ingredients

Avobenzone 3%, Homosalate 9%,

Octisalate 5%, Octocrylene 10%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 4/15/2024

Purpose

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 4/11/2024

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: 4/15/2024

Warning

Keep Out Of Reach Of Children

INSTRUCTIONS FOR USE SECTION

LOINC: 59845-8Updated: 4/11/2024

Directions

• shake well before use

• 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: 4/15/2024

Directions

• shake well before use

• apply liberally 15 minutes before sun exposure

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 4/11/2024

Other information

protect this product from excessive heat and direct sun

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 4/1/2024

Inactive ingredients

isododecane, dimethicone/bis-isobutyl PPG-20 crosspolymer, dicaprylyl carbonate, butyloctyl salicylate, hydrated silica, cocos nucifera (coconut) oil, crambe abyssinica seed oil, helianthus annuus (sunflower) seed oil, neopentyl glycol diheptanoate, polycitronellol acetate, polyester-7, pongamia pinnata seed extract, ricinus communis (castor) seed oil, simmondsia chinensis (jojoba) seed oil, tetrahexyldecyl ascorbate, tocopheryl acetate, tridecane, undecane

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 4/2/2024

Questions?

1-877-978-6286

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