Label: NANOCARE MOISTURIZING SUNSCREEN SPF 50- benzophenone, avobenzone, octisalate, homosalate, and octocrylene lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58466-033-33 - Packager: Deramzone Solutions, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 December 7, 2012
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
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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
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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 every 2 hours
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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
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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
- PRINCIPAL DISPLAY PANEL - 88 mL Tube Carton
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INGREDIENTS AND APPEARANCE
NANOCARE MOISTURIZING SUNSCREEN SPF 50
benzophenone, avobenzone, octisalate, homosalate, and octocrylene lotionProduct 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)
