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

SunBum SPF 50 by

Drug Labeling and Warnings

SunBum SPF 50 by is a Otc medication manufactured, distributed, or labeled by Sun Bum, Product Quest Mfg.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUNBUM SPF 50- octinoxate - 7.50% octisalate - 5.00% octocrylene - 7.00% zinc oxide - 10.00% lotion 
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

Octinoxate - 7.50%                        Sunscreen
Octisalate - 5.00%
Octocrylene - 7.00%
Zinc Oxide - 10.00%

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
Arachidyl Alcohol
Arachidyl Glucoside
Ascorbyl Palmitate
Beeswax
Behenyl Alcohol
Butyrospermum Parkii (Shea) Butter
C12-15 Alkyl Benzoate
Disodium EDTA
Ethylhexylglycerin
Glycerin
Helianthus Annuus (Sunflower) Seed Oil
Hydrogenated Polyisobutene
Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer
Lecithin
Methylisothiazolinone
Oleic Acid
Panthenol
Phenoxyethanol
Phospholipids
Polyester-8
Polyglyceryl-10 Stearate
Sodium Acrylates Copolymer
Sodium Hyaluronate
Sorbitan Oleate
Sorbitol
Tocopheryl Acetate
Triethoxycaprylylsilane
Trimethylpentanediol/Adipic Acid Copolymer
Water
Xanthan Gum

Package Labeling

SUNBUM SPF 50 
octinoxate - 7.50% octisalate - 5.00% octocrylene - 7.00% zinc oxide - 10.00% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-558
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	10   in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE (UNII: V5VD430YW9)	4 g  in 100 mL
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
YELLOW WAX (UNII: 2ZA36H0S2V)
DOCOSANOL (UNII: 9G1OE216XY)
SHEA BUTTER (UNII: K49155WL9Y)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
OLEIC ACID (UNII: 2UMI9U37CP)
PANTHENOL (UNII: WV9CM0O67Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
SORBITOL (UNII: 506T60A25R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIMETHICONOL TRIETHOXYCAPRYLYLSILANE TETRAETHYL SILICATE CROSSPOLYMER (4000000 MW) (UNII: 6CA31A9P15)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-558-03	88 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/22/2015	08/31/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/22/2015	08/31/2018

Labeler - Sun Bum (028642574)

Revised: 2/2020

Document Id: 9f91fb75-5f0c-0569-e053-2995a90aaef7

34390-5

Set id: 3bb495f0-a500-44ed-8358-c4fe6c1fdbb1

Version: 2

Effective Time: 20200227

 

Sun Bum