Label: NIA24 SUN DAMAGE DEFENSE BROAD SPECTRUM UVA/UVB SUNSCREEN SPF-30- avobenzone, homosalate, octisalate, octocrylene lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 43115-102-75 - Packager: NIADYNE INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated December 31, 2020
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Warnings
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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
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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
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INGREDIENTS AND APPEARANCE
NIA24 SUN DAMAGE DEFENSE BROAD SPECTRUM UVA/UVB SUNSCREEN SPF-30
avobenzone, homosalate, octisalate, octocrylene lotionProduct 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)
