Label: NIA24 SUN DAMAGE DEFENSE BROAD SPECTRUM 100 PERCENT MINERAL SUNSCREEN SPF 30- titanium dioxide, zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 43115-101-75 - 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 26, 2018
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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.
- Non-water resistant product.
- 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
Nicotinate, Octyldodecyl Neopentanoate, Neopentyl Glycol Diheptanoate, Aluminum Starch Octenylsuccinate, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Stearic Acid, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Cetyl Alcohol, Magnesium Sulfate, Dimethiconol, Polysilicone-11, Caprylyl Glycol, Bisabolol, Tocopheryl Acetate, Aluminum Hydroxide, Alumina,
Isostearic Acid, Lecithin, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Benzotriazolyl Dodecyl p-Cresol, Disodium EDTA, Fragrance (Parfum) - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NIA24 SUN DAMAGE DEFENSE BROAD SPECTRUM 100 PERCENT MINERAL SUNSCREEN SPF 30
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43115-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 7.1 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 14 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) MYRISTYL NICOTINATE (UNII: 8QWM6I035C) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X) HEXYL LAURATE (UNII: 4CG9F9W01Q) STEARIC ACID (UNII: 4ELV7Z65AP) POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q) CETYL ALCOHOL (UNII: 936JST6JCN) MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I) DIMETHICONOL (14000 CST) (UNII: M2HW98ZA4V) POLYSILICONE-15 (UNII: F8DRP5BB29) CAPRYLYL GLYCOL (UNII: 00YIU5438U) .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM OXIDE (UNII: LMI26O6933) ISOSTEARIC ACID (UNII: X33R8U0062) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43115-101-75 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)
