MINERAL SUNSCREEN SPF 50- zinc oxide, titanium dioxide stick 
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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TOPCARE EVERYDAY MINERAL SUNSCREEN STICK SPF 50

Active ingredients

Titanium Dioxide 7.0%, Zinc Oxide 4.7%

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

beeswax, butyloctyl salicylate, caprylyl glycol, cetyl alcohol, euphorbia cerifera (candelilla) wax, isopropyl palmitate, isostearic acid, neopentyl glycol diethylhexanoate, ozokerite, paraffin, silica

Label

Topcare Everyday Mineral Sunscreen Stick SPF 50

NDC 36800-956-28

1.5 oz (42 g)

TOP48148EF

MINERAL SUNSCREEN SPF 50 
zinc oxide, titanium dioxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-956
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE70 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE47 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CANDELILLA WAX (UNII: WL0328HX19)  
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)  
CERESIN (UNII: Q1LS2UJO3A)  
WHITE WAX (UNII: 7G1J5DA97F)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
PARAFFIN (UNII: I9O0E3H2ZE)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-956-2842 g in 1 CONTAINER; Type 0: Not a Combination Product10/19/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/19/2020
Labeler - TOPCO ASSOCIATES LLC (006935977)

Revised: 4/2021
Document Id: bfe076fa-f220-2c46-e053-2a95a90acee4
Set id: bfe076fa-f21f-2c46-e053-2a95a90acee4
Version: 1
Effective Time: 20210413
 
TOPCO ASSOCIATES LLC