Supreme Shield MOISTURE SUN SPRAY

Drug Labeling and Warnings

Drug Details [pdf]

SUPREME SHIELD- octinoxate, octocrylene, zinc oxide aerosol, spray 
Carver Korea Co.,Ltd

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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Supreme Shield MOISTURE SUN SPRAY

ACTIVE INGREDIENT

ACTIVE INGREDIENT

Uses

Helps prevent sunburn 

Warning

For external use only

do not use on damaged or broken skin

Apply small amount to a clean skin and massage gently with fingertips.

Dosage: Small Amount

Administration: apply to a clean skin and massage gently

Inactive Ingredients

BUTANE
PROPANE
ALCOHOL
HEXAMETHYLDISILOXANE
WATER
ALKYL (C12-15) BENZOATE
DODECAMETHYLPENTASILOXANE
SILICON DIOXIDE
POLYMETHYLSILSESQUIOXANE (11 MICRONS)
DIHYDROXYPROPYLTRIMONIUM
MALTODEXTRIN
1,3-BUTYLENE GLYCOL
GLYCYRRHIZA GLABRA
ALUMINUM HYDROXIDE
SIMMONDSIA CHINENSIS SEED
CUCUMIS MELO WHOLE
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
PSIDIUM GUAJAVA WHOLE
TRIS-BHT MESITYLENE
ALLANTOIN

Fragnance

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

SUPREME SHIELD 
octinoxate, octocrylene, zinc oxide aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58930-019
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.68 g  in 80 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.2 g  in 80 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.576 g  in 80 mL
Inactive Ingredients
Ingredient NameStrength
BUTANE (UNII: 6LV4FOR43R)  
PROPANE (UNII: T75W9911L6)  
ALLANTOIN (UNII: 344S277G0Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58930-019-0180 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/05/201312/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/05/201312/01/2018
Labeler - Carver Korea Co.,Ltd (688442290)
Registrant - Jemian USA Inc. (078822273)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(58930-019)

Revised: 6/2019
Document Id: 748f5957-3ccc-461b-a5c8-c064c650a008
Set id: 0115a682-08c5-4794-8039-9a3dbd72b4aa
Version: 2
Effective Time: 20190611
 
Carver Korea Co.,Ltd