Set and Protect Matte Sheer Setting Mist SPF 45

Set and Protect Matte Sheer Setting Mist SPF 45 by

Drug Labeling and Warnings

Set and Protect Matte Sheer Setting Mist SPF 45 by is a Otc medication manufactured, distributed, or labeled by Pacifica Beauty, LLC, Bell International Laboratories, Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SET AND PROTECT MATTE SHEER SETTING MIST SPF 45- avobenzone, homosalate, octisalate, octocrylene spray 
Pacifica Beauty, LLC

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Set and Protect Matte Sheer Setting Mist SPF 45

Active ingredients Purpose

Avobenzone 2.9% Sunscreen

Homosalate 9.8% Sunscreen

Octisalate 4.9% Sunscreen

Octocrylene 9.5% Sunscreen

Uses

Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer & early skin aging caused by the sun.

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer & early skin aging caused by the sun.

Warnings

For external use only. Do not use on damaged or broken skin. Stop use & ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children.

Directions

Shake well before use. Apply liberally 15 minutes before sun exposure. Use water-resistant sunscreen if swimming or sweating. Reapply after swimming or sweating. Reapply at least every 2 hours. Sun protection measures. Spending time in the sun increases your risk of skin cancer & early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher & other sun protection measures including: - limit time in the sun, especially from 10 a.m. - 2 p.m. - wear long-sleeve shirts, pants, hats & sunglasses.

Inactive ingredients:

Alcohol Denat., Butyloctyl Salicylate, Diheptyl Succinate, Silica Silylate, Coconut Alkanes, Parfum (Natural), Tetrahexyldecyl Ascorbate (Vitamin C), Algae Extract, Ascophyllum Nodosum (Seaweed) Extract, Laminaria Digitata (Algae) Extract, Aqua, Helianthus Annuus (Sunflower) Seed Oil, Hydrolyzed Jojoba Esters, Glycerin, Bisabolol, Capryloyl Glycerin/Sebacic Acid Copolymer, Coco Caprylate/Caprate, Ethyl Ferulate.

Other information

Protect this product from excessive heat & direct sun.

Questions or comments?

Call toll free 1-888-322-2466. Pacifica Beauty LLC Portland, Oregon

Set and Protect Matte Sheer Setting Mist SPF 45 Label

Set and Protect Matte Sheer Setting Mist SPF 45 Label

SET AND PROTECT MATTE SHEER SETTING MIST SPF 45 
avobenzone, homosalate, octisalate, octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 61197-215
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE9.8 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.9 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE9.5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.9 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SUNFLOWER OIL (UNII: 3W1JG795YI)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
FUCUS SERRATUS (UNII: V8K40WNW5B)  
ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ)  
LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)  
ALCOHOL (UNII: 3K9958V90M)  
COCONUT ALKANES (UNII: 1E5KJY107T)  
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
ETHYL FERULATE (UNII: 5B8915UELW)  
COCO-CAPRYLATE (UNII: 4828G836N6)  
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 61197-215-00118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/02/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02002/02/202305/15/2024
Labeler - Pacifica Beauty, LLC (868275517)
Establishment
NameAddressID/FEIBusiness Operations
Bell International Laboratories, Incorporated967781555manufacture(61197-215)

Revised: 5/2024
 

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