SUN BUM HAND CREAM SPF15- avobenzone, homosalate, octisalate, octocrylene cream

Sun Bum Hand Cream SPF15 by

Drug Labeling and Warnings

Sun Bum Hand Cream SPF15 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%,

Homosalate 5%,

Octisalate 2%,

Octocrylene 10%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• Keep outer carton for full information
• 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

• 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, isoamyl cocoate, cetearyl alcohol, arachidyl alcohol, dimethicone, glycerin, behenyl alcohol, styrene/acrylates copolymer, cetearyl glucoside, arachidyl glucoside, fragrance, polyester-8, saccharide isomerate, aprylyl glycol, phenoxyethanol, sorbic acid, xanthan gum xanthan gum, phenoxyethanol, ethylhexylglycerin

Questions?

1-877-978-6286

Package Labeling:

INGREDIENTS AND APPEARANCE

SUN BUM HAND CREAM SPF15 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-637
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	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOAMYL COCOATE (UNII: 14OG46E98E)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
DOCOSANOL (UNII: 9G1OE216XY)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SORBIC ACID (UNII: X045WJ989B)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-637-01	59 mL in 1 CARTON; Type 0: Not a Combination Product	05/19/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/19/2021

Labeler - Sun Bum LLC (028642574)