BODY MIST SPF 55 WEGMAN- avobenzone 3.0% homosalate 15.0% octisalate 5.0% octocrylene 10.0% spray 
Wegman

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 Facts

Active ingredients                   Purpose

Avobenzone 3.0%
Homosalate 15.0%
Octisalate 5.0%
Octocrylene 10.0%                   Sunscreen

Uses

- helps prevent sunburn
- if used as directed with other sun protection messures (see Directions) decreases the risk of skin cancer and early skin aging caused by 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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

spray liberally and spread evenly by hand 15 minutes before sun exposure
• reapply: • after 80 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 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-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

Inactive ingredients

Acrylates/Dimethicone Copolymer
Acrylates/Octylacrylamide Copolymer
Alcohol Denat.
Ascorbyl Palmitate
Cyclopentasiloxane
Dimethicone
Fragrance
Polyester-8
PPG-5-Ceteth-20
Tocopheryl Acetate
Trisiloxane

image descriptionimage description

BODY MIST SPF 55  WEGMAN
avobenzone 3.0% homosalate 15.0% octisalate 5.0% octocrylene 10.0% spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47124-111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone3 g  in 100 g
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate15 g  in 100 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate5 g  in 100 g
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
Ascorbyl Palmitate (UNII: QN83US2B0N)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
Dimethicone (UNII: 92RU3N3Y1O)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
PPG-5-Ceteth-20 (UNII: 4AAN25P8P4)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Trisiloxane (UNII: 9G1ZW13R0G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47124-111-04141 g in 1 CAN; Type 0: Not a Combination Product03/06/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/06/2013
Labeler - Wegman (059650069)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(47124-111) , label(47124-111)

Revised: 1/2018
Document Id: b65a586a-25e4-408a-ab40-23a22d8e454d
Set id: 0d8a717f-bf59-48ce-859c-f6a3b28e57a8
Version: 1
Effective Time: 20180104
 
Wegman