NIA24 SUN DAMAGE DEFENSE BROAD SPECTRUM UVA/UVB SUNSCREEN SPF-30- avobenzone, homosalate, octisalate, octocrylene lotion

NIA24 SUN DAMAGE DEFENSE BROAD SPECTRUM UVA/UVB SUNSCREEN by

Drug Labeling and Warnings

NIA24 SUN DAMAGE DEFENSE BROAD SPECTRUM UVA/UVB SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by NIADYNE INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3%
Homosalate 7.5%
Octisalate 5%
Octocrylene 2.6%

Purpose

Sunscreen

Warnings

• For external use only.
• Do not use on damaged or broken skin.
• Stop use and ask a doctor if rash occurs.
• When using this product, keep out of eyes. Rinse well with water to remove.

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

Directions

• Apply liberally 15 minutes before sun exposure.
• Reapply at least every 2 hours.
• Use a water-resistant sunscreen if swimming or sweating.
• 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 witha broad spectrum SPF 15 or higher and other sun protection measures, including:
  - Limit time in the sun, especially from 10 am – 2 pm.
  - Wear long-sleeve shirts, pants, hats, and sunglasses.
• Children under 6 months of age: Ask a doctor.

Other information

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Aqua (Water, Eau), Dipropylene Glycol, Myristyl Nicotinate, Polyester-8, Caprylyl Methicone, Cyclopentasiloxane, Glycine Soja (Soybean) Seed Extract, Ceramide NG, Ceramide NP, Lycium Chinense Fruit Extract, Vaccinum Angustifolium (Blueberry) Fruit Extract Arctostaphylos Uva Ursi Leaf Extract, Mangifera Indica (Mango) Seed Butter, Dipotassium Glycyrrhizate, Tocopheryl Acetate, Sorbitan Sesquioleate, Cetyl Alcohol, Methyl Glucose Sesquistearate, Potassium Cetyl Phosphate, Hydrogenated Palm Glycerides, Butylene Glycol, Caprylyl Glycol, Sodium Acrylate/Sodium Acryloyidimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80, Fragrance (Parfum),
Polyacrylate-15, Polyacrylate -17, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Phenoxyethanol, Chlorphenesin, Xanthan Gum, Cyclohexasiloxane, Potassium Hydroxide, C11-15 Pareth-7, C11-15 Pareth-40, Sodium Laureth-12 Sulfate, Disodium Lauryl Sulfosuccinate, Sorbitan Oleate, Potassium Sorbate, Hexylene Glycol, Hydroxyisohexyl 3-cyclohexene carboxaldehyde

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NIA24 SUN DAMAGE DEFENSE BROAD SPECTRUM UVA/UVB SUNSCREEN  SPF-30
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43115-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
MYRISTYL NICOTINATE (UNII: 8QWM6I035C)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
SOYBEAN (UNII: L7HT8F1ZOD)
CERAMIDE NG (UNII: C04977SRJ5)
CERAMIDE NP (UNII: 4370DF050B)
LYCIUM CHINENSE FRUIT (UNII: TG711Q7A1Q)
BLUEBERRY (UNII: 253RUG1X1A)
ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
CETYL ALCOHOL (UNII: 936JST6JCN)
METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
ISOHEXADECANE (UNII: 918X1OUF1E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
AMMONIUM ACRYLOYL DIMETHYLTAURATE/METHACRYLATE, DIMETHYLACRYLAMIDE AND METHACRYLIC ACID COPOLYMER, PPG-3 GLYCERYL TRIACRYLATE CROSSLINKED (100000 MW) (UNII: WR7H9IW2XX)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
XANTHAN GUM (UNII: TTV12P4NEE)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
C11-15 PARETH-7 (UNII: 261HPE0IS3)
C11-15 PARETH-40 (UNII: L774F88277)
SODIUM LAURETH-12 SULFATE (UNII: 8M492LDU23)
DISODIUM LAURYL SULFOSUCCINATE (UNII: P160Q81342)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43115-102-75	1 in 1 BOX	12/26/2018
1		75 mL in 1 TUBE; 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	12/26/2018

Labeler - NIADYNE INC (113220482)

Registrant - NIADYNE INC (113220482)