Supreme Shield BASE 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
BASE SUN SPRAY

Uses

Helps prevent sunburn 

ACTIVE INGREDIENT

Active Ingredients: OCTINOXATE 2.1%, OCTOCRYLENE 1.5%, ZINC OXIDE 0.72%

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
DODECAMETHYLPENTASILOXANE
WATER
1,3-BUTYLENE GLYCOL
ALKYL (C12-15) BENZOATE
ALUMINUM STARCH OCTENYLSUCCINATE
METHYL TRIMETHICONE
POLYMETHYLSILSESQUIOXANE (11 MICRONS)
CAPRYLYL TRISILOXANE
PEG-10 DIMETHICONE (600 CST)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
METHYL METHACRYLATE
ALUMINUM HYDROXIDE
SODIUM CHLORIDE
CAPRYLYL GLYCOL
DIMETHICONE
CURCUMA LONGA WHOLE
ETHYLHEXYLGLYCERIN
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
GRAPEFRUIT PEEL
APRICOT FRUIT VOLATILE OIL
1,2-HEXANEDIOL
IRIS GERMANICA WHOLE
EDETIC ACID
MELIA AZEDARACH FRUIT
MELIA AZEDERACH LEAF
MELIA AZEDARACH BARK
OYSTER SHELL CALCIUM CARBONATE, CRUDE
.BETA.-BISABOLOL
MORINGA OLEIFERA SEED OIL
OCIMUM BASILICUM FLOWERING TOP
OCIMUM TENUIFLORUM TOP
ALOE VERA LEAF
POTASSIUM SORBATE
GLYCERIN
CAPRYLHYDROXAMIC ACID
SODIUM BENZOATE
TROPOLONE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SUPREME SHIELD 
octinoxate, octocrylene, zinc oxide aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58930-018
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	.576 g  in 80 mL

Inactive Ingredients
Ingredient Name	Strength
BUTANE (UNII: 6LV4FOR43R)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58930-018-01	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(58930-018)

Revised: 6/2019

Document Id: 4cedb677-70b2-4796-a5f6-107afe98692e

34390-5

Set id: 24e35b4d-4410-470f-864a-760d955550b9

Version: 3

Effective Time: 20190611