Label: BEACH BB SCALP AND HAIR PROTECT MIST SPF30- avobenzone, homosalate, octisalate, and octocrylene spray
- NDC Code(s): 83187-144-02
- Packager: Demert Brands, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 28, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
-
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
-
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
- Inactive Ingredients
- Questions ?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 60 mL Bottle Box
-
INGREDIENTS AND APPEARANCE
BEACH BB SCALP AND HAIR PROTECT MIST SPF30
avobenzone, homosalate, octisalate, and octocrylene sprayProduct 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)
