SUN BUM PREMIUM SUNSCREEN BROWNING SPF 15- avobenzone, homosalate, octisalate, octocrylene 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 Premium Sunscreen Browning Lotion SPF 15

Drug Facts

Active ingredients

Avobenzone 2%, Homosalte 5%,
Octisalate 2%, 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 immediately.

Directions

• shake well before use • apply liberally 15 minutes before sun exposure • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • children under 6 months of age: ask a doctor 

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 value of 15 or higher and other sun protection measures including:

Other information

protect this product from excessive heat and direct sun

Inactive ingredients

water, caprylic/capric triglyceride, cocos nucifera (coconut) oil, glyceryl stearate, PEG-100 stearate, fragrance, caramel, cetyl alcohol, aloe barbadensis leaf juice, argania spinosa (argan) kernel oil, aleurites moluccana (kukui) seed oil, coffea arabica (coffee) seed oil, caprica papaya fruit extract, zingiber officinale (ginger) root extract, helianthus annuus (sunflower) extract, macadamia ternifolia seed oil, glycerin, hydrolyzed algin, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, acrylate/c 10-30 alkyl acrylate crosspolymer, tocopheryl acetate, tocopherol, magnesium sulfate, manganese sulfate, isohexadecane, polysorbate 60, caffeine, phenoxyethanol, ethylhexylglycerin, sodium hydroxide, blue no.1, red no.33, red no.4, yellow no.6

Questions?

1-877-978-6286

Package Labeling:

Bottle4

SUN BUM PREMIUM SUNSCREEN BROWNING SPF 15 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69039-643
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE50 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE20 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
PAPAYA JUICE (UNII: AZ5XLY17KM)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
COCONUT OIL (UNII: Q9L0O73W7L)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CARAMEL (UNII: T9D99G2B1R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARGAN OIL (UNII: 4V59G5UW9X)  
KUKUI NUT (UNII: J87WJ3E7VW)  
ARABICA COFFEE OIL (UNII: IK55HKE887)  
GINGER (UNII: C5529G5JPQ)  
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
MACADAMIA OIL (UNII: 515610SU8C)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TOCOPHEROL (UNII: R0ZB2556P8)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
MANGANESE SULFATE (UNII: W00LYS4T26)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
CAFFEINE (UNII: 3G6A5W338E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
SODIUM ALGINATE (UNII: C269C4G2ZQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69039-643-01250 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2022
Labeler - Sun Bum LLC (028642574)

Revised: 2/2022
Document Id: d72f4c3b-3ea9-5a84-e053-2995a90a9557
Set id: 22b6555a-30a6-4d4d-9a8c-5a23fda864d7
Version: 2
Effective Time: 20220204
 
Sun Bum LLC