SPF 30 SCALP AND HAIR MIST- avobenzone, homosalate, octisalate, octocrylene spray

SPF 30 Scalp and Hair Mist by

Drug Labeling and Warnings

SPF 30 Scalp and Hair Mist by is a Otc medication manufactured, distributed, or labeled by Sun Bum LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Avobenzone 3%, Homosalate 10%,

Octisalate 5%, Octocrylene 4%

Purpose

Sunscreen

Warnings

For external use only

Flammable: do you not use near heat, flame, or while smoking

Do not use

on damaged or broken skin

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

• hold container 4 to 6 inches from scalp and skin to apply
• spray liberally and spread evenly by hand 15 minutes before sun exposure.
• do not spray directly into face. Spray on hands then apply to face and hairline.
• do not apply in windy conditions 
• use in well ventilated area
• 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. Do not store above 104°F/40°C.

Inactive ingredients

water

Questions?

call 1-877-978-6286

Package Labeling:

INGREDIENTS AND APPEARANCE

SPF 30 SCALP AND HAIR MIST 
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-280
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-280-00	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2019

Labeler - Sun Bum LLC (028642574)