SUN BUM FACE AND BODY STICK 40- avobenzone, homosalate, octisalate, octocrylene stick SUN BUM FACE AND BODY STICK 40 0.7 OZ - PEGGED- avobenzone, homosalate, octisalate, octocrylene stick

Sun Bum Face and Body Stick 40 0.7 OZ - pegged by

Drug Labeling and Warnings

Sun Bum Face and Body Stick 40 0.7 OZ - pegged by is a Otc medication manufactured, distributed, or labeled by Sun Bum, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Active ingredients:

Avobenzone 2.5%, Homosalate 3.5%, Octisalate 2.5%, Octocrylene 5%

Purpose

Sunscreen

Uses

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

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.

Warnings

Keep Out Of Reach Of Children

Directions

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

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 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

Other information

protect this product from excessive heat and direct sun

Inactive ingredients

Inactive ingredients

water, carthamus tinctorius (safflower) oleosomes, sodium stearate, butyloctyl salicylate, euphorbia cerifera (candelilla) wax, propanediol, sorbitan olivate, VP/hexadecene copolymer, glycerin, fragrance, phenoxyethanol, C18-38 alkyl hydroxystearoyl stearate, pongamia pinnata seed extract, tocopheryl acetate, ethylhexylglycerin, yellow 5 lake

Questions

Questions? 1-877-978-6286

Primary Artwork

Primary Artwork

INGREDIENTS AND APPEARANCE

SUN BUM FACE AND BODY STICK 40 
avobenzone, homosalate, octisalate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-670
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	35 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	25 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM STEARATE (UNII: QU7E2XA9TG)
C18-38 ALKYL HYDROXYSTEAROYL STEARATE (UNII: WW4FVB2PEM)
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
CANDELILLA WAX (UNII: WL0328HX19)
PROPANEDIOL (UNII: 5965N8W85T)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)
GLYCERIN (UNII: PDC6A3C0OX)
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SORBITAN OLIVATE (UNII: MDL271E3GR)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-670-01	1 in 1 CARTON	08/29/2024
1	NDC: 69039-670-00	20 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/29/2024

SUN BUM FACE AND BODY STICK 40 0.7 OZ - PEGGED 
avobenzone, homosalate, octisalate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-816
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	35 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	25 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM STEARATE (UNII: QU7E2XA9TG)
C18-38 ALKYL HYDROXYSTEAROYL STEARATE (UNII: WW4FVB2PEM)
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
CANDELILLA WAX (UNII: WL0328HX19)
PROPANEDIOL (UNII: 5965N8W85T)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)
GLYCERIN (UNII: PDC6A3C0OX)
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SORBITAN OLIVATE (UNII: MDL271E3GR)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-816-01	1 in 1 CARTON	08/29/2024
1	NDC: 69039-816-00	20 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/29/2024

Labeler - Sun Bum, LLC (028642574)