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, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, 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, PORTULACA OLERACEA EXTRACT, CINNAMOMUM CASSIA BARK EXTRACT, LACTOBACILLUS/SOYBEAN FERMENT EXTRACT, PHYTOSPHINGOSINE, ACETYLPHYTOSPHINGOSINE, SAUSSUREA INVOLUCRATA EXTRACT, LILIUM CANDIDUM FLOWER EXTRACT, CHRYSANTHEMUM INDICUM FLOWER EXTRACT, ALCOHOL, SODIUM HYDROXIDE

PURPOSE

Purpose : Sunscreen

WARNINGS

Warnings : 1.Discontinue use if abnormal situations occur. If you continue to use, it may worsen symptoms, consult dermatologist, etc 2.Do not use over wounds, rashes, inflammations or other troubled areas. 3. Keep out of reach of children.

Directions

Directions: Dispense an appropriate amount on your palm and use fingers to gently spread on your face and neck.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of tubeImage of tube

ONCE FINISHING 
octinoxate, titanium dioxide, octisalate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69716-310
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.48 g  in 8 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.32 g  in 8 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.16 g  in 8 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.15 g  in 8 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69716-310-018 mL in 1 TUBE; Type 0: Not a Combination Product11/01/201711/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/01/201711/01/2019
Labeler - NoTS Co.,Ltd (689004599)
Registrant - NoTS Co.,Ltd (689004599)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co.,LTD. Gwanjeong Factory689512611manufacture(69716-310)

Revised: 12/2019
 
NoTS Co.,Ltd