DERMATONE SUNSCREEN SPF 30- avobenzone 3.00% homosalate 10.00% octisalate 5.00% octocrylene 10.00% lotion 
Beaumont Products

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 ingredient

Avobenzone - 3.00%
Homosalate - 10.00%
Octisalate - 5.00%
Octocrylene - 10.00%

Purpose

Sunscreen

Uses

Uses • helps prevent sunburn • if used as directed with other sun protection mesures (see Direction) decreases the risk of skin cancer

WarningFor 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

apply liberally 15 minutes before sun exposure
reapply:
after 80 minutes of swimming or sweating
immediately after towel drying
at least 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

Other Information

protect this product from excessive heat and direct sun

Inactive Ingredients:
Acrylates/C10-30 Alkyl Acrylate Crosspolymer
Benzyl Alcohol
Caprylic/Capric Triglyceride
Chlorphenesin
Diethylhexyl Syringylidenemalonate
Disodium EDTA
Ethylhexyl Palmitate
Oleth-3
Polyamide-8
Sodium Ascorbyl Phosphate
Sorbitol
Tocopherol
Triethanolamine
Water

image description

DERMATONE SUNSCREEN SPF 30 
avobenzone 3.00% homosalate 10.00% octisalate 5.00% octocrylene 10.00% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65449-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone3 g  in 100 mL
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate10 g  in 100 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate5 g  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
Benzyl Alcohol (UNII: LKG8494WBH)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Chlorphenesin (UNII: I670DAL4SZ)  
Diethylhexyl Syringylidenemalonate (UNII: 3V5U97P248)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Ethylhexyl Palmitate (UNII: 2865993309)  
Oleth-3 (UNII: BQZ26235UC)  
Sodium Ascorbyl Phosphate (UNII: 836SJG51DR)  
Sorbitol (UNII: 506T60A25R)  
Tocopherol (UNII: R0ZB2556P8)  
TROLAMINE (UNII: 9O3K93S3TK)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65449-001-0130 mL in 1 TUBE; Type 0: Not a Combination Product12/27/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/27/2016
Labeler - Beaumont Products (120935804)
Registrant - Product Quest Mfg (120935804)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg120935804manufacture(65449-001) , label(65449-001)

Revised: 6/2018
Document Id: 6a6ab2d6-6dc3-4d78-8d0e-99f5e5668c7d
Set id: e3760253-ce9a-49bd-b646-03e443c514df
Version: 1
Effective Time: 20180608
 
Beaumont Products