Label: DERMATONE SUNSCREEN SPF 30- avobenzone 3.00% homosalate 10.00% octisalate 5.00% octocrylene 10.00% lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 65449-001-01 - Packager: Beaumont Products
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated June 8, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- WarningFor external use only
- Keep out of reach of children.
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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
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DERMATONE SUNSCREEN SPF 30
avobenzone 3.00% homosalate 10.00% octisalate 5.00% octocrylene 10.00% lotionProduct 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)
