Label: COTZ PEDIATRIC SPF 40 SUNSCREEN- zinc oxide lotion
-
Contains inactivated NDC Code(s)
NDC Code(s): 58892-518-01 - Packager: Fallien Cosmeceuticals, LTD.
- 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 December 19, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients:
- 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:
-
Directions:
- Apply liberally 15 minutes before sun exposure.
- Reapply:
- -
- After 40 minutes of swimming or sweating
- -
- Immediately after towel drying
- -
- At least every 2 hours
- Children under 6 months: Ask a doctor
-
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 value 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-sleeved shirts, pants, hats, and sunglasses
-
Inactive Ingredients:
C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Getyl PEG/PPG 10/1 Dimethicone, Cyelohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dlmethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Methicone, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydraxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexadecyl Ascorbate, Triethanolamine, Triethoxycaprylylsilane, Water
- Other Information:
-
Principal Display Panel – SPF 40 100g Carton Label
PEDIATRICIAN RECOMMENDED
CoTZ®
PEDIATRIC
The Healthier SunscreenTM Gentle Mineral ComplexTM #1 Rated UV Protection*
Will Not Irritate or StingHelps Prevent Heat Build-Up in Skin
which can Damage the Dermis100% Free of:
Chemical Sunscreens & Fragrances
SPF 40
Broad
Spectrum
UVA-UVBEasy to Apply
Water Resistant
(40 minutes)Net Wt. 3.5 oz/100 g
-
INGREDIENTS AND APPEARANCE
COTZ PEDIATRIC SPF 40 SUNSCREEN
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58892-518 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 200 mg in 1 g Inactive Ingredients Ingredient Name Strength Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Caprylhydroxamic Acid (UNII: UPY805K99W) Caprylyl Glycol (UNII: 00YIU5438U) Cetyl PEG/PPG-10/1 Dimethicone (HLB 5) (UNII: 035JKJ76MT) Cyclomethicone 6 (UNII: XHK3U310BA) Cyclomethicone 5 (UNII: 0THT5PCI0R) Dimethicone 100 (UNII: RO266O364U) Dimethicone/Diene Dimethicone Crosspolymer (UNII: RSA9I561OK) Edetate Disodium (UNII: 7FLD91C86K) Methicone (20 cst) (UNII: 6777U11MKT) Microcrystalline Wax (UNII: XOF597Q3KY) PEG-10 Dimethicone (600 cst) (UNII: 8PR7V1SVM0) PEG-30 Dipolyhydroxystearate (UNII: 9713Q0S7FO) Polyglyceryl-4 Isostearate (UNII: 820DPX33S7) Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F) Polysorbate 20 (UNII: 7T1F30V5YH) Sodium Chloride (UNII: 451W47IQ8X) Stearyl Dimethicone (400 MPA.S AT 50C) (UNII: R327X197HY) Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Trolamine (UNII: 9O3K93S3TK) Triethoxycaprylylsilane (UNII: LDC331P08E) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58892-518-01 1 in 1 CARTON 1 100 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/07/2012 Labeler - Fallien Cosmeceuticals, LTD. (958388357) Establishment Name Address ID/FEI Business Operations Custom Analytics LLC 144949372 ANALYSIS(58892-518) Establishment Name Address ID/FEI Business Operations Process Technologies & Packaging 809172885 MANUFACTURE(58892-518)