BEACH BB SCALP AND HAIR PROTECT MIST SPF30- avobenzone, homosalate, octisalate, and octocrylene spray

Beach BB Scalp and Hair Protect Mist SPf30 by

Drug Labeling and Warnings

Beach BB Scalp and Hair Protect Mist SPf30 by is a Otc medication manufactured, distributed, or labeled by Demert Brands, LLC, Solo Laboratories In. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Avobenzone 3% ; Homosalate 10%;Octisalate 5 %; Octocrylene 4%

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 doctor if rash occurs.

Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure * reapply:
• After 40 minutes of swimming or sweating * immediately after towel drying
• At least every 2 hours
• 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 15 or higher and other sun protection measures including:
  • Limit the time in the sun, especially from 10 am – 2 pm
  • Wear long sleeve shirts, pants, hats, and sunglasses
• Children under 6 months ask a doctor
• Spray in close proximity (2-3") to the scalp

Other information

• Protect the product in the container from excessive heat and direct sun.

Inactive Ingredients

Alcohol Denat., Butyloctyl Salicylate, Polyester-8, Acrylates/OctylAcrylamide Copolymer, Diethylhexyl 2-6-Naphthalate,Fragrance, Caprylic/Capric Triglyceride, Crambe Maritima Leaf Extract, Oryza Sativa (Rice) Bran Oil, Tocopherol Acetate.

Questions ?

Call 1-813-903-0434

SPL UNCLASSIFIED SECTION

Dist. by DeMert Brands. PO BOX 82163. Tampa, FL 33682.

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Box

NOT YOUR
M♥THER'S®

SUNSCREEN
BEACH
BABE®
SCALP & HAIR MIST

30

Broad Spectrum SPF 30
UVA/UVB Protection
Water Resistant (40 minutes)

2 fl oz (60 mL)

INGREDIENTS AND APPEARANCE

BEACH BB SCALP AND HAIR PROTECT MIST SPF30 
avobenzone, homosalate, octisalate, and octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83187-144
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	Avobenzone	3 g  in 100 mL
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	10 g  in 100 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	5 g  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
ButylOctyl Salicylate (UNII: 2EH13UN8D3)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
Rice Bran Oil (UNII: LZO6K1506A)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CRAMBE MARITIMA LEAF (UNII: NO0DI2V62B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
ALCOHOL (UNII: 3K9958V90M)
.GAMMA.-NONALACTONE (UNII: I1XGH66S8P)
Coumarin (UNII: A4VZ22K1WT)
Benzaldehyde (UNII: TA269SD04T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ACETOPHENONE (UNII: RK493WHV10)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83187-144-02	1 in 1 BOX	05/01/2023
1		59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/01/2023

Labeler - Demert Brands, LLC (059175344)

Registrant - Solo Laboratories In (078831987)

Establishment
Name	Address	ID/FEI	Business Operations
Solo Laboratories In		078831987	MANUFACTURE(83187-144) , LABEL(83187-144) , PACK(83187-144)