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Sun Bum 15 Premium Sunscreen Tanning Oil

Sun Bum 15 Premium Sunscreen Tanning Oil

Approved
Approval ID

3c468710-ca71-79be-e063-6394a90a8cfd

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 Code69039-794
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 (23)

PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OILInactive
Code: 66YXD4DKO9
Classification: IACT
SCLEROCARYA BIRREA SEED OILInactive
Code: WDO4TLS35F
Classification: IACT
ARGANIA SPINOSA KERNEL OILInactive
Code: 4V59G5UW9X
Classification: IACT
CAMELLIA SINENSIS LEAFInactive
Code: W2ZU1RY8B0
Classification: IACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED OILInactive
Code: 3W1JG795YI
Classification: IACT
COCOS NUCIFERA (COCONUT) OILInactive
Code: Q9L0O73W7L
Classification: IACT
PERSEA GRATISSIMA (AVOCADO) OILInactive
Code: 6VNO72PFC1
Classification: IACT
OLEA EUROPAEA (OLIVE) FRUIT OILInactive
Code: 6UYK2W1W1E
Classification: IACT
CAMELLIA OLEIFERA SEED OILInactive
Code: T1PE06G0VE
Classification: IACT
CORN OILInactive
Code: 8470G57WFM
Classification: IACT
OCTOCRYLENEActive
Quantity: 100 mg in 1 mL
Code: 5A68WGF6WM
Classification: ACTIB
ALOE BARBADENSIS LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
SIMMONDSIA CHINENSIS (JOJOBA) SEED WAXInactive
Code: 47X6Y9FJJ2
Classification: IACT
LINUM USITATISSIMUM (LINSEED) SEED OILInactive
Code: 84XB4DV00W
Classification: IACT
THEOBROMA CACAO (COCOA) SEED BUTTERInactive
Code: 512OYT1CRR
Classification: IACT
APRICOT KERNEL OILInactive
Code: 54JB35T06A
Classification: IACT
PASSIFLORA EDULIS SEED OILInactive
Code: F3VOA31UHQ
Classification: IACT
MACADAMIA TERNIFOLIA SEED OILInactive
Code: 515610SU8C
Classification: IACT
OCTISALATEActive
Quantity: 50 mg in 1 mL
Code: 4X49Y0596W
Classification: ACTIB
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
AVOBENZONEActive
Quantity: 30 mg in 1 mL
Code: G63QQF2NOX
Classification: ACTIB
HOMOSALATEActive
Quantity: 100 mg in 1 mL
Code: V06SV4M95S
Classification: ACTIB
ROSA CANINA FRUIT OILInactive
Code: CR7307M3QZ
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

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

OTC - ACTIVE INGREDIENT SECTION

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

Active Ingredients

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

INSTRUCTIONS FOR USE SECTION

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

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: 1/1/2025

Directions

• shake well before use

• 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

INACTIVE INGREDIENT SECTION

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

Inactive Ingredients

Mineral Oil, Aloe Barbadensis Leaf Extract, Prunus Armeniaca (Apricot) Kernel Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Helianthus Annuus (Sunflower) Seed Oil, Cocos Nucifera (Coconut) Oil, Linum Usitatissimum (Linseed) Seed Oil, Persea Gratissima (Avocado) Oil, Argania Spinosa Kernel Oil, Macadamia Ternifolia Seed Oil, Olea Europaea (Olive) Fruit Oil, Passiflora Edulis Seed Oil, Rosa Canina Fruit Oil, Camellia Oleifera Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Camellia Sinensis Leaf Powder, Sclerocarya Birrea Seed Oil, Hydrogenated Vegetable Oil, Fragrance

OTC - QUESTIONS SECTION

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

Questions?

1-877-978-6286

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Sun Bum 15 Premium Sunscreen Tanning Oil - FDA Drug Approval Details