SunBum SPF 50 by Sun Bum / Product Quest Mfg. SunBum SPF 50

Drug Details [pdf]

SUNBUM SPF 50- octisalate - 5.00% octinoxate - 7.50% oxybenzone - 6.00% zinc oxide - 7.00% cream
Sun Bum

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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SunBum SPF 50

Active ingredients Purpose

Octisalate - 5.00% Sunscreen
Octinoxate - 7.50%
Oxybenzone - 6.00%
Zinc Oxide - 7.00%

Uses

- helps prevent sunburn
- if used as directed with other sun protection messures ( see Directions) decreases the risk of skin cancer and early skin aging caused by 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 a.m. – 2 p.m.
wear long-sleeve shirts, pants, hats, and sunglasses
children under 6 months: Ask a doctor

Inactive ingredients

Aloe Barbadensis Leaf Extract
Beeswax
Cetyl Dimethicone
Cetyl PEG/PPG-10/1 Dimethicone
Cyclohexasiloxane
Cyclopentasiloxane
Diisopropyl Adipate
DMDM Hydantoin
Ethylhexyl Palmitate
Ethylhexyl Stearate
Fragrance
Glycerin
Hydrated Silica
Hydrogenated Castor Oil
Polyethylene
Sodium Chloride
Theobroma Cacao (Cocoa) Seed Butter
Tocopheryl Acetate
Triethoxycaprylylsilane
Water

Package Labeling

image description

SUNBUM SPF 50
octisalate - 5.00% octinoxate - 7.50% oxybenzone - 6.00% zinc oxide - 7.00% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-559
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	7 in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE (UNII: V5VD430YW9)	4 g in 100 mL
YELLOW WAX (UNII: 2ZA36H0S2V)
CETYL DIMETHICONE 45 (UNII: IK315POC44)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3) (UNII: G300307ZXP)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCOA BUTTER (UNII: 512OYT1CRR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 69039-559-01	1 in 1 CARTON	02/10/2011	08/31/2018
1		30 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/10/2011	08/31/2018

Labeler - Sun Bum (028642574)

Revised: 2/2020

Document Id: 9f9218de-616e-0783-e053-2a95a90a3a03

Set id: 4f1432b2-b694-4a45-be38-ff44c8ca464d

Version: 2

Effective Time: 20200227

Sun Bum