SUN BUM PREMIUM SUNSCREEN BROWNING SPF 15- avobenzone, homosalate, octisalate, octocrylene lotion

Sun Bum Premium Sunscreen Browning SPF 15 by

Drug Labeling and Warnings

Sun Bum Premium Sunscreen Browning SPF 15 by is a Otc medication manufactured, distributed, or labeled by Sun Bum LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Avobenzone 2%, Homosalte 5%,
Octisalate 2%, Octocrylene 10%

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 skin 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

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:

•  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

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:

INGREDIENTS AND APPEARANCE

SUN BUM PREMIUM SUNSCREEN BROWNING SPF 15 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-643
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	50 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	20 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-643-01	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2022

Labeler - Sun Bum LLC (028642574)