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

Dermatone Sunscreen SPF 30 by

Drug Labeling and Warnings

Dermatone Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by Beaumont Products, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65449-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	Avobenzone	3 g  in 100 mL
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	10 g  in 100 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	5 g  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65449-001-01	30 mL in 1 TUBE; Type 0: Not a Combination Product	12/27/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/27/2016

Labeler - Beaumont Products (120935804)

Registrant - Product Quest Mfg (120935804)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		120935804	manufacture(65449-001) , label(65449-001)