SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene spray 
OLD EAST MAIN CO.

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.

----------

Care One  Sunscreen Spray spf 70
983.000/983aa

active ingredients

Avobenzone, Homosalate, Octisalate, Octocrylene

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

Flammable

Keep away from fire or flame.

do not use 

stop use and ask a doctor if

keep out of reach of children

if swallowed, get medical help or contact a Poison Conrol Center right away

direction

■ spray liberally and spread evenly by hand 15 minutes before sun exposure
■ apply to all skin exposed to the sun
■ hold container 4 to 6 inches from the skin to apply
■ do not spray directly into face. Spray on hands then apply to face.
■ do not apply in windy conditions
■ use in a well-ventilated area and avoid inhalation
■ 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 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
■ children under 6 months of age: Ask a doctor

other information

inactive ingredients

alcohol denat., octyldodecyl neopentanoate, acrylates/octylacrylamide copolymer, diethylhexyl 2,6-naphthalate, tocopheryl acetate, fragrance

May stain or damage some fabrics of surfaces

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

principal display panel

STUDIO SELECTION

SUN

BEACH GUARD

SUN & WATER

Protection

SUNSCREEN SPRAY

BROAD SPECTRUM SPF 70

Compare to Neutrogena Beach Defense Sunscreen Spray

SPF 70

Octinoxate & Oxybenzone Free

Dermatologist Tested

NET WT 6.5 OZ (184 g)

image description

SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-983
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone90 g  in 1 g
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate2250 g  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate250 g  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene640 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-983-54184 g in 1 CAN; Type 0: Not a Combination Product01/18/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/18/2021
Labeler - OLD EAST MAIN CO. (068331990)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(55910-983)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(55910-983)

Revised: 3/2022
Document Id: f30c222d-cd24-4dec-bd9f-e2b300940ad0
Set id: 00ee1dc6-b4f3-4ae3-890c-8e37f6d3fe3a
Version: 4
Effective Time: 20220317
 
OLD EAST MAIN CO.