NANOCARE MOISTURIZING SUNSCREEN SPF 50- benzophenone, avobenzone, octisalate, homosalate, and octocrylene lotion

nanocare by

Drug Labeling and Warnings

nanocare by is a Otc medication manufactured, distributed, or labeled by Deramzone Solutions, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

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

Purpose

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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

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

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

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

NANOCARE   MOISTURIZING SUNSCREEN SPF 50
benzophenone, avobenzone, octisalate, homosalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58466-033
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzophenone (UNII: 701M4TTV9O) (Benzophenone - UNII:701M4TTV9O)	Benzophenone	60 mg  in 1 mL
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	100 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	80 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58466-033-33	1 in 1 CARTON
1		88 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	10/15/2012

Labeler - Deramzone Solutions, Inc. (136116865)

Establishment
Name	Address	ID/FEI	Business Operations
Deramzone Solutions, Inc.		136116865	MANUFACTURE(58466-033)