NANOCARE  MOISTURIZING SUNSCREEN SPF 50- benzophenone, avobenzone, octisalate, homosalate, and octocrylene lotion 
Deramzone Solutions, Inc.

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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nanocare for skin
Moisturizing Sunscreen SPF 50

Drug Facts

Active ingredients

Benzophenone-3 6.0%
Butyl Methoxydibenzoylmethane 3.0%
Ethylhexyl Salicylate 5.0%
Homosalate 10.0%
Octocrylene 8.0%

Purpose

Uses

Warnings

For 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

Inactive ingredients

USP water, potassium cetyl phosphate, alcohol, dicaprylyl maleate, sorbitol, bis-stearyl/ethylenediamine/neopentyl glycol/stearyl hydrogenated dimmer dilinoleate copolymer, cetyl alcohol, lecithin, aloe barbadensis leaf juice, carbomer, tocopheryl acetate, methylparaben, propylparaben, triethanolamine

Manufactured by:
Dermazone Solutions, Inc.
2440 30th Avenue North St. Petersburg, FL 33713 USA

Distributed by: Universal Sales & Marketing, Inc.

PRINCIPAL DISPLAY PANEL - 88 mL Tube Carton

nanocare
for skin

Moisturizing Sunscreen
SPF 50

Broad Spectrum Protection

WATER RESISTANT
(80 MINUTES)

Clinical Skin Care
with Lyphazome® Technology

3.0 FL OZ (88 mL)

PRINCIPAL DISPLAY PANEL - 88 mL Tube Carton
NANOCARE   MOISTURIZING SUNSCREEN SPF 50
benzophenone, avobenzone, octisalate, homosalate, and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58466-033
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzophenone (UNII: 701M4TTV9O) (Benzophenone - UNII:701M4TTV9O) Benzophenone60 mg  in 1 mL
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate100 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene80 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
potassium cetyl phosphate (UNII: 03KCY6P7UT)  
alcohol (UNII: 3K9958V90M)  
dioctyl maleate (UNII: OD88G8439L)  
sorbitol (UNII: 506T60A25R)  
cetyl alcohol (UNII: 936JST6JCN)  
aloe vera leaf (UNII: ZY81Z83H0X)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
methylparaben (UNII: A2I8C7HI9T)  
propylparaben (UNII: Z8IX2SC1OH)  
trolamine (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58466-033-331 in 1 CARTON
188 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/15/2012
Labeler - Deramzone Solutions, Inc. (136116865)
Establishment
NameAddressID/FEIBusiness Operations
Deramzone Solutions, Inc.136116865MANUFACTURE(58466-033)

Revised: 12/2012
Document Id: 4d7b98e6-4b6a-461b-8735-7d889c233685
Set id: 5a68508b-f1fa-4f03-b28a-554e24cf58d6
Version: 2
Effective Time: 20121207
 
Deramzone Solutions, Inc.