SUNSCREEN SPF 30 CAREONE- avobenzone 3% homosalate 10% octisalate 5% octocrylene 2% oxybenzone 4% spray 
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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.

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Drug Facts

Active ingredients                                                                         Purpose
Avobenzone 3.0%.........................................................................Sunscreen
Homosalate 10.0%........................................................................Sunscreen
Octisalate 5.0%............................................................................Sunscreen
Octocrylene 2.0%..........................................................................Sunscreen
Oxybenzone 4.0%.........................................................................Sunscreen

Uses • helps prevent sunburn • higher SPF gives more sunburn protection

Warnings
For external use only
Flammable: Do not use near heat, flame, or while smoking.
Do not use on damaged or broken skin
When using this product • Keep out of eyes. Rinse eyes with water to remove.
• Keep away from face to avoid breathing it • Do not puncture or incinerate. Contents under
pressure. Do not store at temperatures above 120ºF.
Stop use and ask a doctor if rash occurs

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 • 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 • 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

Other information • protect this product from excessive heat and direct sun. • may stain fabrics.

Inactive ingredients

Acrylates/Octylacrylamide Copolymer,
Alcohol Denat., Caprylic/Capric Triglyceride, Diethylhexyl
Syringylidenemalonate, Fragrance, Glycerin, Retinyl Palmitate,
Stearoxytrimethylsilane, Tocopherol.

image description

SUNSCREEN SPF 30  CAREONE
avobenzone 3% homosalate 10% octisalate 5% octocrylene 2% oxybenzone 4% spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-360
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) Homosalate10 g  in 100 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate5 g  in 100 g
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene2 g  in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Diethylhexyl Syringylidenemalonate (UNII: 3V5U97P248)  
Glycerin (UNII: PDC6A3C0OX)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
Stearoxytrimethylsilane (UNII: 9862TW94B2)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-360-05153 g in 1 CAN; Type 0: Not a Combination Product04/13/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/13/2018
Labeler - CareOne (809183973)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(41520-360) , label(41520-360)

Revised: 5/2018
Document Id: ed371ce3-a1da-4121-b05a-21126bb4321e
Set id: 54339206-8a48-4757-8bde-6b83333410d2
Version: 1
Effective Time: 20180525
 
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