Supreme Shield SIMMERING 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 SIMMERING 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)
SIMMONDSIA CHINENSIS SEED
MICA
ALUMINUM HYDROXIDE
PHYLLOSTACHYS RETICULATA RESIN
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE
1,3-BUTYLENE GLYCOL
GLYCERIN
BAMBUSA TEXTILIS STEM
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
OENOTHERA BIENNIS FLOWER
IMPERATA CYLINDRICA ROOT
PHENOXYETHANOL
POLYETHYLENE GLYCOL 1000
ALLANTOIN
CAPRYLYL GLYCOL
CERAMIDE 3
CHOLESTEROL
HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW)
CARBOMER 934
ETHYLHEXYLGLYCERIN

Fragnance

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SUPREME SHIELD 
octinoxate, octocrylene, zinc oxide aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58930-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.68 g  in 80 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.2 g  in 80 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.576 g  in 80 mL

Inactive Ingredients
Ingredient Name	Strength
BUTANE (UNII: 6LV4FOR43R)
PROPANE (UNII: T75W9911L6)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
MICA (UNII: V8A1AW0880)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALLANTOIN (UNII: 344S277G0Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58930-020-01	80 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/05/2013	12/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/05/2013	12/01/2018

Labeler - Carver Korea Co.,Ltd (688442290)

Registrant - Jemian USA Inc. (078822273)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(58930-020)

Revised: 6/2019

Document Id: 9b8c5727-51b9-4046-96b7-a7c02c431bf1

34390-5

Set id: b2af0b03-8d7c-4c3c-b8cc-5e72a8a1abff

Version: 2

Effective Time: 20190611