Sun Bum SPF 15 Moisturizing Tanning Oil

Drug Labeling and Warnings

Drug Details [pdf]

SUN BUM SPF 15 MOISTURIZING TANNING- avobenzone, homosalate, octisalate, octocrylene oil 
Sun Bum, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Sun Bum SPF 15 Moisturizing Tanning Oil

Drug Facts

Active Ingredients

Avobenzone 3.00%
Homosalate 10.00%
Octisalate 5.00%

Octocrylene 10.00%

Purpose

Sunscreen

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.

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 product is swallowed, get medical help or contact a Poison Control Center right away. 

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
• 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 of 15 or higher and other sun protection measures. including: Limit time in the sun, especially from 10 am - 2 pm.
• Wear long-sleeve shirts, pants, hats, and sunglasses.
• Children under 6 months: Ask a doctor.

Other information

Protect this product from excessive heat and direct sun.

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, Camellia Oleifera Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Camellia Sinensis Leaf Powder, Sclerocarya Birrea Seed Oil, Hydrogenated Vegetable Oil, Fragrace.

Questions or Comments?

Call + 1 (877) 978-6286

Package Labeling:

SUN BUM SPF 15 MOISTURIZING TANNING 
avobenzone, homosalate, octisalate, octocrylene oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-211
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
JOJOBA OIL (UNII: 724GKU717M)
ALMOND OIL (UNII: 66YXD4DKO9)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
LINSEED OIL (UNII: 84XB4DV00W)
AVOCADO OIL (UNII: 6VNO72PFC1)
ARGAN OIL (UNII: 4V59G5UW9X)
MACADAMIA OIL (UNII: 515610SU8C)
OLIVE OIL (UNII: 6UYK2W1W1E)
CAMELLIA OIL (UNII: T1PE06G0VE)
COCOA BUTTER (UNII: 512OYT1CRR)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-211-01	266 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/24/2017	05/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/24/2017	05/01/2019

Labeler - Sun Bum, LLC (028642574)

Revised: 10/2019

Document Id: 950cdd44-e63e-5f5d-e053-2995a90ad8b3

34390-5

Set id: 9f80997c-a826-4874-8da7-531925e0b8b9

Version: 4

Effective Time: 20191016

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