Sunscreen SPF 30 by Sun Bum / Product Quest Mfg Sunscreen SPF 30

Sunscreen SPF 30 by

Drug Labeling and Warnings

Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by Sun Bum, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUNSCREEN SPF 30  SUN BUM- avobenzone 3.0% homosalate 5.0% octisalate 3.0% octocrylene 10.0% 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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Sunscreen SPF 30

Active ingredients                                                                                            Purpose

Avobenzone 2.0%, Homosalate 5.0%, Octisalate 2.0%, Octocrylene 10.0%     Sunscreen

Uses helps prevent sunburn If used as directed with other sun protection measures (see Directions), decreases the rick 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 a.m. – 2 p.m.
wear long-sleeve shirts, pants, hats, and sunglasses
children under 6 months: Ask a doctor

Inactive ingredients

Water
Butyloctyl Salicylate
Hydrated Silica
Styrene/Acrylates Copolymer
Dimethicone
VP/Hexadecene Copolymer
Polyester-8
Caprylyl Methicone
Ethylhexyl Stearate
Trideceth-6
Glyceryl Stearate
PEG-100 Stearate
Fragrance
Sodium Polyacrylate
Behenyl Alcohol
Dimethyl Capramide
Ethylhexylglycerin
Trimethylsiloxysilicate
Xanthan Gum
Polyaminopropyl Biguanide
Tocopheryl Acetate
BHT
Disodium EDTA
Methylisothiazolinone

Package Labeling

SUNSCREEN SPF 30   SUN BUM
avobenzone 3.0% homosalate 5.0% octisalate 3.0% octocrylene 10.0% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-562
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
DIMETHICONE (UNII: 92RU3N3Y1O)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
DOCOSANOL (UNII: 9G1OE216XY)
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
XANTHAN GUM (UNII: TTV12P4NEE)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-562-06	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/16/2017	08/31/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/16/2017	08/31/2018

Labeler - Sun Bum (028642574)

Revised: 2/2020

Document Id: 9f9281ab-306f-8410-e053-2a95a90a0fa2

34390-5

Set id: c52cde81-2b0f-4b7a-8a37-d02d3788c814

Version: 2

Effective Time: 20200227