NOTS UV PROTECTION SUN- octinoxate, titanium dioxide, zinc oxide, octisalate cream 
NoTS 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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ACTIVE INGREDIENT

Active Ingredient: ETHYLHEXYL METHOXYCINNAMATE 6.8%, TITANIUM DIOXIDE 5.66%, ZINC OXIDE 5.0%, ETHYLHEXYL SALICYLATE 4.5%

INACTIVE INGREDIENT

Inactive Ingredients:

WATER, CYCLOPENTASILOXANE, METHICONE, ALUMINUM HYDROXIDE, STEARIC ACID, DIMETHICONE, DIPROPYLENE GLYCOL, PEG-10 DIMETHICONE, NIACINAMIDE, GLYCERIN, ALUMINUM STEARATE, DICAPRYLYL CARBONATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PORTULACA OLERACEA EXTRACT, BUTYLENE GLYCOL, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, POLYMETHYLSILSESQUIOXANE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, CAPRYLYL GLYCOL, CITRUS GRANDIS (GRAPEFRUIT) PEEL OIL, OLEA EUROPAEA (OLIVE) FRUIT OIL, CITRUS AURANTIFOLIA (LIME) OIL, RIBES NIGRUM (BLACK CURRANT) SEED OIL, ROSE FLOWER OIL, ILLICIUM VERUM (ANISE) FRUIT/SEED OIL, MICROCRYSTALLINE CELLULOSE, CELLULOSE GUM, ALOE BARBADENSIS LEAF EXTRACT, PENTYLENE GLYCOL, 1,2-HEXANEDIOL, PANTHENOL, POLYGLYCERYL-6 POLYRICINOLEATE, LAURUS NOBILIS LEAF EXTRACT, SILICA, POLYURETHANE-11, TOCOPHERYL ACETATE, LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER/LEAF/STEM EXTRACT, GLYCERYL CAPRYLATE, ADENOSINE, CAMELLIA SINENSIS LEAF WATER, BENZYL ALCOHOL, DEHYDROACETIC ACID, HAMAMELIS VIRGINIANA (WITCH HAZEL) WATER, ROSA DAMASCENA FLOWER WATER, SODIUM HYALURONATE, ORIGANUM VULGARE LEAF EXTRACT, CHAMAECYPARIS OBTUSA LEAF EXTRACT, SALIX ALBA (WILLOW) BARK EXTRACT, LACTOBACILLUS/SOYBEAN FERMENT EXTRACT, SCUTELLARIA BAICALENSIS ROOT EXTRACT, CINNAMOMUM CASSIA BARK EXTRACT, HIPPOPHAE RHAMNOIDES FRUIT EXTRACT, PHOSPHOLIPIDS, PHYTOSPHINGOSINE, PHYTOSTEROLS, CERAMIDE 3, HIPPOPHAE RHAMNOIDES OIL, TROPOLONE

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:

Stop use and ask dermatologist or doctor if

•signs of redness, skin swelling, itchy spots, irritation or rash and other appear

•the above signs appear in the applied area by direct rays of the sun

Do not use over

•wounds rashes inflammations other troubled areas.

Do not stay too long in the sun, even while using a sunscreen product.

When using

•Avoid the eye area

•must close the cap after using

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DESCRIPTION

Uses: UV-Ray protection

Directions: Dispense appropriate amount on your hand. Spread over your face and other skin area exposed to sun.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

NOTS UV PROTECTION SUN 
octinoxate, titanium dioxide, zinc oxide, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69716-170
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4.76 g  in 70 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.96 g  in 70 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION3.50 g  in 70 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3.15 g  in 70 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69716-170-0170 g in 1 CARTON; Type 0: Not a Combination Product01/02/201602/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/02/201602/01/2020
Labeler - NoTS Co.,Ltd (689004599)
Registrant - NoTS Co.,Ltd (689004599)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co.,LTD. Gwanjeong Factory689512611manufacture(69716-170)

Revised: 3/2020
 
NoTS Co.,Ltd