SUN BUM PREMIUM SPF 15 SUNSCREEN TANNING- avobenzone, homosalate, octisalate, octocrylene oil 
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 SPF 15 Sunscreen Tanning Oil

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 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 • 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 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

mineral oil, aloe barbadensis leaf extract, prunus armeniaca (apricot) kernel oil, simmondsia chinensis (jojoba) seed oil, prunus amygdalus dulcis (sweet almond) oil, helianthus annuus (sunflower) seed oil, cocos nucifera (coconut) oil, linum usitatissimum (linseed) seed oil, persea gratissima (avocado) oil, argania spinosa kernel oil, macadamia ternifolia seed oil, olea europaea (olive) fruit oil, passiflora edulis seed oil, rosa canina fruit oil, camellia oleifera seed oil, theobroma cacao (cocoa) seed butter, camellia sinensis leaf powder, sclerocarya birrea seed oil, hydrogenated vegetable oil, fragrance

Questions?

Call 1-877-978-6286

Package Labeling:

Label

SUN BUM PREMIUM SPF 15 SUNSCREEN TANNING 
avobenzone, homosalate, octisalate, octocrylene oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69039-278
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
MINERAL OIL (UNII: T5L8T28FGP)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
APRICOT KERNEL OIL (UNII: 54JB35T06A)  
JOJOBA OIL (UNII: 724GKU717M)  
ALMOND OIL (UNII: 66YXD4DKO9)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
COCONUT OIL (UNII: Q9L0O73W7L)  
LINSEED OIL (UNII: 84XB4DV00W)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
ARGAN OIL (UNII: 4V59G5UW9X)  
MACADAMIA OIL (UNII: 515610SU8C)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
PASSIFLORA EDULIS SEED OIL (UNII: F3VOA31UHQ)  
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
CAMELLIA OIL (UNII: T1PE06G0VE)  
COCOA BUTTER (UNII: 512OYT1CRR)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69039-278-00250 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2019
Labeler - Sun Bum LLC (028642574)

Revised: 2/2022
Document Id: d73e275e-1d37-528b-e053-2a95a90a64d4
Set id: 96fd64db-a1fa-4751-9b8a-091efc0c9614
Version: 2
Effective Time: 20220204
 
Sun Bum LLC