28 REMEDY JUVENILE SUN BB LIGHT BEIGE- octinoxate, zinc oxide, titanium dioxide 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 7.0% , Zinc Oxide 6.8%, Titanium Dioxide 6.2%

INACTIVE INGREDIENT

Inactive Ingredients:

Water, Cetyl Ethylhexanoate, Butylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, 4-Methylbenzylidene Camphor, Caprylic/Capric Triglyceride, Hydrogenated Polyisobutene, Niacinamide, Butyl Methoxydibenzoylmethane, Sorbitan Sesquioleate, Talc, Benzophenone-3, Sodium Chloride, Sorbitan Isostearate, Calcium Stearate, Polyethylene, Triethoxycaprylylsilane, Iron Oxides(CI 77492), Disteardimonium Hectorite, Zanthoxylum Piperitum Fruit Extract, Pulsatilla Koreana Extract, Usnea Barbata (Lichen) Extract, Iron Oxides(CI 77491), Iron Oxides(CI 77499), Disodium EDTA, Adenosine, Aloe Barbadensis Leaf Juice, Salix Alba (Willow) Bark Extract, Lactobacillus/Soybean Ferment Extract, Portulaca Oleracea Extract, Origanum Vulgare Leaf Extract, Cinnamomum Cassia Bark Extract, Scutellaria Baicalensis Root Extract, Chamaecyparis Obtusa Leaf Extract, Punica Granatum Fruit Extract, Ascorbyl Tetraisopalmitate, Melia Azadirachta Extract, Betula Alba Juice, Vitis Vinifera (Grape) Seed Extract, Hydrolyzed Collagen, Tocopheryl Acetate, Snail Secretion Filtrate, Opuntia Ficus-Indica Callus Culture Extract, Camellia Sinensis Leaf Extract, Allium Sativum (Garlic) Bulb Extract, Brassica Oleracea Italica (Broccoli) Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Spinacia Oleracea (Spinach) Leaf Extract, Salicornia Herbacea Extract, Vitis Vinifera (Grape) Fruit Extract, Juglans Regia (Walnut) Seed Extract, Solanum Lycopersicum (Tomato) Fruit Extract, Avena Sativa (Oat) Meal Extract

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. Use your fingers to gently spread evenly on your face.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

28 REMEDY JUVENILE SUN BB LIGHT BEIGE 
octinoxate, zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69716-280
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate3.15 g  in 45 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION3.06 g  in 45 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide2.79 g  in 45 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69716-280-021 in 1 CARTON12/01/201612/01/2018
1NDC:69716-280-0145 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/01/201612/01/2018
Labeler - NoTS Co.,Ltd (689004599)
Registrant - NoTS Co.,Ltd (689004599)
Establishment
NameAddressID/FEIBusiness Operations
Nowcos.Co.,Ltd689914984manufacture(69716-280)

Revised: 12/2018
 
NoTS Co.,Ltd