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Sun Bum Premium Sunscreen Face Stick Broad Spectrum SPF 30 Sunscreen

Sun Bum Premium Sunscreen Face Stick Broad Spectrum SPF 30 Sunscreen

Approved
Approval ID

36dc7c13-eaf7-b415-e063-6294a90a5784

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 26, 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 Code69039-696
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 26, 2025
FDA Product Classification

INGREDIENTS (15)

HOMOSALATEActive
Quantity: 100 mg in 1 g
Code: V06SV4M95S
Classification: ACTIB
EUPHORBIA CERIFERA (CANDELILLA) WAXInactive
Code: WL0328HX19
Classification: IACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)Inactive
Code: T9296U138P
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
OCTISALATEActive
Quantity: 50 mg in 1 g
Code: 4X49Y0596W
Classification: ACTIB
PARAFFINInactive
Code: I9O0E3H2ZE
Classification: IACT
OCTYL PALMITATEInactive
Code: UYY8LE6Q5Y
Classification: IACT
CERESINInactive
Code: Q1LS2UJO3A
Classification: IACT
BEESWAXInactive
Code: 2ZA36H0S2V
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
POLYETHYLENEInactive
Code: UG00KM4WR7
Classification: IACT
ASCORBYL PALMITATEInactive
Code: QN83US2B0N
Classification: IACT
AVOBENZONEActive
Quantity: 30 mg in 1 g
Code: G63QQF2NOX
Classification: ACTIB
BUTYLOCTYL SALICYLATEInactive
Code: 2EH13UN8D3
Classification: IACT
OCTOCRYLENEActive
Quantity: 100 mg in 1 g
Code: 5A68WGF6WM
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Primary Packaging

OG SPF 30 Face Stick

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

OTC - ACTIVE INGREDIENT SECTION

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

Active Ingredient

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

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

DOSAGE & ADMINISTRATION SECTION

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

Directions

• apply liberally 15 minutes before sun exposure

OTHER SAFETY INFORMATION

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

Other Information

protect this product from excessive heat and direct sun

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

INACTIVE INGREDIENT SECTION

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

Inactive Ingredients

paraffin wax, octyl palmitate, ozokerite, euphorbia cerifera (candelilla) wax, beeswax, butyloctyl salicylate, fragrance, polyethylene, polycrylene, cetyl alcohol, tocopheryl acetate, ascorbyl palmitate

OTC - QUESTIONS SECTION

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

Questions?

1-877-978-6286

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Sun Bum Premium Sunscreen Face Stick Broad Spectrum SPF 30 Sunscreen - FDA Drug Approval Details