TOPCO TOPCARE EVERYDAY MINERAL SUNSCREEN ZINC OXIDE SPF 50- zinc oxide lotion 
TOPCO ASSOCIATES LLC

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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TOPCO TOPCARE EVERYDAY MINERAL SUNSCREEN LOTION ZINC OXIDE SPF 50

Active ingredient

Zinc Oxide 21.6%

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not use


When using this product

Stop use and ask a doctor if

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

water, C12-15 alkyl benzoate, caprylic/capric triglyceride, styrene/acrylates copolymer, octydodecyl citrate crosspolmyer, phenyl trimethicone, cetyl PEG/PPG-10/1 dimethicone, dimethicone, glycerin, polyhydroxystearic acid, ethyl methicone, cetyl dimethicone, silica, chrysanthemum parthenium (feverfew) flower/leaf/stem juice, glyceryl behenate, phenethyl alcohol, caprylyl glycol, bis-divinyl dimethicone/PEG-10 dimethicone crosspolymer, sodium chloride, phenoxyethanol, chlorphenesin

TOP48146A

TOPCO TOPCARE EVERYDAY MINERAL SUNSCREEN ZINC OXIDE SPF 50 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-251
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE216 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLYCERIN (UNII: PDC6A3C0OX)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TANACETUM PARTHENIUM FLOWER (UNII: 7TVV9D7I89)  
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
WATER (UNII: 059QF0KO0R)  
ETHYL METHICONE (8 MPA.S) (UNII: 3YWG8XYT8H)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-251-0989 mL in 1 TUBE; Type 0: Not a Combination Product12/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34612/02/2020
Labeler - TOPCO ASSOCIATES LLC (006935977)

Revised: 1/2022
Document Id: d5034e20-3ce2-a4c4-e053-2995a90a9527
Set id: d501a94e-3bcd-d8e4-e053-2a95a90a33b0
Version: 3
Effective Time: 20220107
 
TOPCO ASSOCIATES LLC