NIA24 SUN DAMAGE DEFENSE BROAD SPECTRUM 100 PERCENT MINERAL SUNSCREEN SPF 30- titanium dioxide, zinc oxide lotion
NIADYNE INC

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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NIA24 SUN DAMAGE DEFENSE BROAD SPECTRUM SPF 30 100% MINERAL SUNSCREEN

Active Ingredients

TITANIUM DIOXIDE 7.064%

ZINC OXIDE 14.00%

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.
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

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

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)

4001653404_SunDamageMINERAL_SPF30_75ml_Carton_FNL_8.28.18

NIA24 SUN DAMAGE DEFENSE BROAD SPECTRUM 100 PERCENT MINERAL SUNSCREEN SPF 30
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43115-101
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	12/26/2018

Labeler - NIADYNE INC (113220482)

Registrant - NIADYNE INC (113220482)