SUN BUM SIGNATURE CLEAR SPF 50- octisalate, octocrylene, zinc oxide lotion 
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 Signature Lotion Clear SPF 50

Drug Facts

Active ingredients

Octisalate 5%, Octocrylene 10%. Zinc oxide 10%

Purpose

Sunscreen

Uses

Warnings

For externel 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

Other information

Inactive ingredients

water, C12-15 alkyl benzoate, triethylpentanediol/ adipic acid copolymer, butyrospermum parkii (shee) butter, glycerin, polyster-8, arachidyl alcohol, panthenol, aloe barbadensis leaf juice, tocopheryl acetate, sodium hyaluronate, ascorbyl palmitate, beeswax, behenylalcohol, arachidyl glucoside, sorbitan oleate, sorbitol, lecithin, xanthan gum, oleic acid, glyceryl caprylate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, triethoxycaprylylate, disodium EDTA, phenoxyethanol, caprylyl glycol, ethylhexylglycerin

Questions?

1(877)978-6286

Package Labeling:44ml

BottleBottle2

Package Labeling:88ml

Bottle3Bottle4

SUN BUM SIGNATURE CLEAR SPF 50 
octisalate, octocrylene, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69039-617
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
GLYCERIN (UNII: PDC6A3C0OX)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
PANTHENOL (UNII: WV9CM0O67Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
DOCOSANOL (UNII: 9G1OE216XY)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
SORBITOL (UNII: 506T60A25R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
OLEIC ACID (UNII: 2UMI9U37CP)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69039-617-0144 mL in 1 BOTTLE; Type 0: Not a Combination Product11/11/2020
2NDC:69039-617-0288 mL in 1 BOTTLE; Type 0: Not a Combination Product11/11/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/11/2020
Labeler - Sun Bum LLC (028642574)

Revised: 2/2022
Document Id: d73c8765-0e86-fde2-e053-2995a90ae4c2
Set id: b5f52185-aed4-3fc8-e053-2995a90a3332
Version: 3
Effective Time: 20220204
 
Sun Bum LLC