SUN BUM SKIN CARE ESSENTIALS KIT- avobenzone, homosalate, octisalate, octocrylene 
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 Skin Care Essentials Kit

Drug Facts

Active ingredients

Avobenzone 3%, Homosalate 10%,

Octisalate 5%, Octocrylene 10%

Purpose

Sunscreen

Uses

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 right away.

Directions

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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

Other information

protect this product from excessive heat and direct sun

Inactive ingredients (SPF 30 moisturizing sunscreen lotion)

water, polyglyceryl-6 stearate, dimethicone, cetearyl alcohol, capryloyl glycerin/sebacic acid copolymer, hydrated silica, hibiscus sabdariffa fruit extract, niacinamide, cocos nucifera (coconut) fruit extract, helianthus annuus (sunflower) extract, lactobacillus, lactobacillus ferment, musa sapientum (banana) flower extract, musa sapientum (banana) fruit extract, musa sapientum (banana) leaf extract, musa sapientum (banana) peel extract, musa sapientum (banana) pulp extract, lysolecithin, erythritol, glucose, glycerin, arachidyl alcohol, arachidyl glucoside, behenyl alcohol, cetearyl glucoside, fragrance, polyglyceryl-6 behenate, pullulan, sclerotium gum, tocopherol, xanthan gum, phenoxyethanol, ethylhexylglycerin

Questions?

1-877-978-6286

Package Labeling:

outer package
Inner Package

SUN BUM SKIN CARE ESSENTIALS KIT 
avobenzone, homosalate, octisalate, octocrylene kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69039-645
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69039-645-011 in 1 KIT08/17/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 15 mL
Part 1 of 1
DAILY SUNSCREEN MOISTURIZER SPF 30 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Item Code (Source)NDC:69039-646
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
HIBISCUS SABDARIFFA WHOLE (UNII: UH3Z91Y49Y)  
LACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)  
WATER (UNII: 059QF0KO0R)  
POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
NIACINAMIDE (UNII: 25X51I8RD4)  
COCONUT (UNII: 3RT3536DHY)  
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
MUSA X PARADISIACA FLOWER (UNII: DG5B0M0NGY)  
BANANA (UNII: 4AJZ4765R9)  
MUSA X PARADISIACA LEAF (UNII: 2UIJ27N6ED)  
BANANA PEEL (UNII: 04CM0T683C)  
LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z)  
ERYTHRITOL (UNII: RA96B954X6)  
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
GLYCERIN (UNII: PDC6A3C0OX)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
DOCOSANOL (UNII: 9G1OE216XY)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
POLYGLYCERYL-6 BEHENATE (UNII: 4T2L7QI313)  
PULLULAN (UNII: 8ZQ0AYU1TT)  
BETASIZOFIRAN (UNII: 2X51AD1X3T)  
TOCOPHEROL (UNII: R0ZB2556P8)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69039-646-0115 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/17/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/17/2021
Labeler - Sun Bum LLC (028642574)

Revised: 8/2021
Document Id: ca523d8d-78ba-40c7-e053-2995a90a86c7
Set id: 90574d55-4655-4902-b811-7523ace216d8
Version: 1
Effective Time: 20210824
 
Sun Bum LLC