NEOGEN DERMALOGY DAY-LIGHT PROTECTION SUN SCREEN SPF50- titanium dioxide, zinc oxide, octinoxate cream

NEOGEN DERMALOGY Day-Light Protection Sun Screen SPF50 by

Drug Labeling and Warnings

NEOGEN DERMALOGY Day-Light Protection Sun Screen SPF50 by is a Otc medication manufactured, distributed, or labeled by OUTIN FUTURES CORP., COSON Co., Ltd._Osan Plant. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium Dioxide 0.90%
Octinoxate 7.50%
Zinc Oxide 2.80%

PURPOSE

Helps to prevent sunburn

INDICATIONS & USAGE

Apply liberally 15 minutes before sun exposure. Reapply at least every two hours.

Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses.

Ask a doctor to use for children under 6 months.

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure. Reapply at least every two hours.

WARNINGS

For external use only.

Do not use on damaged or broken skin.

When using this product, keep out of eyes. Rinse with water to remove.

Stop using and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

INACTIVE INGREDIENT

Water, Glycerin, Butylene Glycol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, C12-15 Alkyl Benzoate, Hexanediol, Isoamyl P-Methoxycinnamate, Dicaprylyl Carbonate, Cetearyl Alcohol, Xanthan Gum, Polysorbate 20, Sodium Hyaluronate, Glyceryl Stearate, Peg-100 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Portulaca Oleracea Extract, Lavandula Angustifolia (Lavender) Oil, Phyllanthus Emblica Fruit Extract, Rubus Idaeus(Raspberry) Fruit Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Euterpe Oleracea Fruit Extract, Ammonium Acryloyldimethyltaurate/Vp Copolymer, Carbomer, Lippia Citriodora Leaf Extract, Rosa Damascena Flower Extract, Tocopheryl Acetate, Angelica Archangelica Root Extract, Beta-Glucan, Hibiscus Sabdariffa Flower Extract, Artemisia Absinthium Extract, Arnica Montana Flower Extract, Polyhydroxystearic Acid, Alumina, Gentiana Lutea Root Extract, Achillea Millefolium Extract, Litsea Cubeba Fruit Oil, Citrus Limon (Lomon) Fruit Oil, Eucalyptus Globulus Leaf Oil, Cedrus Atlantica Wood Oil, Disodium Edta, Potassium Hydroxide, Citrus Aurantium Dulcis(Orange) Oil, Aluminum Stearate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NEOGEN DERMALOGY DAY-LIGHT PROTECTION SUN SCREEN SPF50 
titanium dioxide, zinc oxide, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69924-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.51 g  in 46.78 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.42 g  in 46.78 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	1.31 g  in 46.78 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BEMOTRIZINOL (UNII: PWZ1720CBH)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
HEXANEDIOL (UNII: ZIA319275I)
AMILOXATE (UNII: 376KTP06K8)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
PURSLANE (UNII: M6S840WXG5)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)
RASPBERRY (UNII: 4N14V5R27W)
LOWBUSH BLUEBERRY (UNII: G90PX41VP0)
ACAI (UNII: 46AM2VJ0AW)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
LIPPIA CITRIODORA LEAF (UNII: 9B1F4HKA9O)
ROSA DAMASCENA FLOWER (UNII: JWB78P295A)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ANGELICA ARCHANGELICA ROOT (UNII: DTN01M69SN)
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)
WORMWOOD (UNII: F84709P2XV)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ALUMINUM OXIDE (UNII: LMI26O6933)
GENTIANA LUTEA ROOT (UNII: S72O3284MS)
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)
LITSEA OIL (UNII: 2XIW34BN6O)
CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)
EUCALYPTUS OIL (UNII: 2R04ONI662)
CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
ORANGE OIL (UNII: AKN3KSD11B)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69924-006-02	1 in 1 CARTON	12/14/2017
1	NDC: 69924-006-01	46.78 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/14/2017

Labeler - OUTIN FUTURES CORP. (688864073)

Registrant - OUTIN FUTURES CORP. (688864073)

Establishment
Name	Address	ID/FEI	Business Operations
COSON Co., Ltd._Osan Plant		689847210	manufacture(69924-006)