SUN BUM TINTED SPF15 SUNSCREEN SANDBAR- avobenzone, octinoxate, octisalate stick 
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 Tinted SPF15 Sunscreen Lip Balm Sandbar

Drug Facts

Active ingredients

Avobenzone 1.9%, Octinoxate 7.1%, Octisalate 4.9%

Purpose

Sunscreen

Uses

• helps prevent sunburn • if used as directed with other sun protection measures, (see Directions) decreases the risk of skin cancer and early 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 swallowed, get medical help or contact a Poison Control Center immediately.

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 • use a water resistant sunscreen if swimming or sweating • 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: • limit time in the sun, especially from 10 a.m.- 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses

Other information

protect this product from excessive heat and direct sun

Inactive ingredients

cocos nucifera (coconut) oil, beeswax, butyrospermum parkii (shea) butter, ricinus communis (castor) seed oil, olea europaea (olive) fruit oil, caprylic/capric triglyceride, theobroma grandiflorum seed butter, titanium dioxide, copernicia cerifera (carnauba) wax, flavor, helianthus annuus (sunflower)seed oil, limnanthes alba (meadowfoam) seed oil, aloe barbadensis leaf extract, simmondsia chinensis (jojoba) seed oil, carthamus tinctorius (safflower) seed oil, euphorbia cerifera (candelilla) wax, tocopherol, jojoba esters, octyldodecyl oleate, stevia rebaudiana extract, iron oxides, silica

Questions?

call 1 (877) 978-6286

Package Labeling:

Label4

SUN BUM TINTED SPF15 SUNSCREEN SANDBAR 
avobenzone, octinoxate, octisalate stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69039-263
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE71 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE19 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE49 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
COCONUT OIL (UNII: Q9L0O73W7L)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
SHEA BUTTER (UNII: K49155WL9Y)  
CASTOR OIL (UNII: D5340Y2I9G)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
JOJOBA OIL (UNII: 724GKU717M)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
CANDELILLA WAX (UNII: WL0328HX19)  
TOCOPHEROL (UNII: R0ZB2556P8)  
OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69039-263-004.25 g in 1 CARTRIDGE; Type 0: Not a Combination Product04/15/201801/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/15/201801/01/2021
Labeler - Sun Bum LLC (028642574)

Revised: 2/2022
 
Sun Bum LLC