NOTS ONCE FINISHING- octinoxate, titanium dioxide, octisalate, zinc oxide 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%, TITANIUM DIOXIDE 4.02%, ETHYLHEXYL SALICYLATE 2%, ZINC OXIDE 1.92%

INACTIVE INGREDIENT

INACTIVE INGREDIENT:

WATER, CYCLOPENTASILOXANE, PROPYLENE GLYCOL, BUTYLENE GLYCOL, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN, ISODODECANE, ISOEICOSANE, ISOHEXADECANE, CAPRYLYL METHICONE, PEG-10 DIMETHICONE, TALC, METHICONE, CYCLOMETHICONE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, NIACINAMIDE, ALUMINUM HYDROXIDE, ALUMINUM STEARATE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, DISTEARDIMONIUM HECTORITE, DIMETHICONE, MAGNESIUM SULFATE, BETAINE, C12-14 PARETH-3, PALMITIC ACID, CHROMIUM OXIDE GREENS, OCTYLDODECANOL, ECHIUM PLANTAGINEUM SEED OIL, CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES, TOCOPHEROL, TOCOPHERYL ACETATE, CITRUS MEDICA LIMONUM (LEMON) PEEL OIL, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL, CITRUS AURANTIFOLIA (LIME) OIL, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, PINUS SYLVESTRIS LEAF OIL, EUCALYPTUS GLOBULUS LEAF OIL, ADENOSINE, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, ULTRAMARINES, ARGANIA SPINOSA KERNEL OIL, OLEA EUROPAEA (OLIVE) FRUIT OIL, ROSA DAMASCENA FLOWER WATER, BENZYL ALCOHOL, DEHYDROACETIC ACID, CALENDULA OFFICINALIS FLOWER EXTRACT, GLYCERIN, SAMBUCUS NIGRA FLOWER EXTRACT, PALMITOYL HEXAPEPTIDE-12, CERAMIDE 3, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, HEDERA HELIX (IVY) EXTRACT, ALLIUM SATIVUM (GARLIC) BULB EXTRACT, PINUS PALUSTRIS LEAF EXTRACT, LAMIUM ALBUM FLOWER EXTRACT, ARNICA MONTANA FLOWER EXTRACT, ARCTIUM MAJUS ROOT EXTRACT, NASTURTIUM OFFICINALE EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, METHYLPARABEN, BUTYLPARABEN, ETHYLPARABEN, PROPYLPARABEN, ISOBUTYLPARABEN, CAMELLIA SINENSIS LEAF EXTRACT, SODIUM HYALURONATE, LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER EXTRACT, PORTULACA OLERACEA EXTRACT, CHAMAECYPARIS OBTUSA LEAF EXTRACT, SALIX ALBA (WILLOW) BARK EXTRACT, ORIGANUM VULGARE LEAF EXTRACT, SCUTELLARIA BAICALENSIS ROOT EXTRACT, CINNAMOMUM CASSIA BARK EXTRACT, LACTOBACILLUS/SOYBEAN FERMENT EXTRACT, ACETYLPHYTOSPHINGOSINE, SAUSSUREA INVOLUCRATA EXTRACT, LILIUM CANDIDUM FLOWER EXTRACT, CHRYSANTHEMUM INDICUM FLOWER EXTRACT, ALCOHOL, SODIUM HYDROXIDE

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 Protection

- Helps Prevent Sunburn

Directions:

With appropriate amount, use your fingers to gently spread evenly on your face to even out the texture prior to makeup.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

NOTS ONCE FINISHING 
octinoxate, titanium dioxide, octisalate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69716-320
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.80 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.20 g  in 30 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.60 g  in 30 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.57 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69716-320-021 in 1 CARTON02/01/201811/01/2019
1NDC:69716-320-0130 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/201811/01/2019
Labeler - NoTS Co.,Ltd (689004599)
Registrant - NoTS Co.,Ltd (689004599)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co.,LTD. Gwanjeong Factory689512611manufacture(69716-320)

Revised: 12/2019
 
NoTS Co.,Ltd