NAELI TINTED MINERAL MOISTURIZER SUNSCREEN SPF 50, DARK- zinc oxide liquid

NAELI Tinted Mineral Moisturizer Sunscreen SPF 50, Dark by

Drug Labeling and Warnings

NAELI Tinted Mineral Moisturizer Sunscreen SPF 50, Dark by is a Otc medication manufactured, distributed, or labeled by ALLI LLC, Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredients

Zinc Oxide 18.00%

Purpose

Sunscreen

Uses:

• Helps prevent sunburn.
• Higher SPF gives more sunburn protection.
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings:

For external use only not intended for ingestion.

Do not use

• on damaged or broken skin.

When using this product

• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

rash or irritation develops and lasts.

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 and as needed.
• Children under 6 months of age: ask a doctor.
• 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 with a broad spectrum SPF of 15 or higher and other sun protection measures including: 
• Limit time in the sun, especially from 10 a.m.- 2 p.m.
•  Wear long-sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients:

Adansonia Digitata Oil, Aloe Barbadensis Leaf Extract, Argania Spinosa Kernel Oil, Butylene Glycol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Caprylyl Methicone, Carbomer, Ceramide NG, Cetearyl Alcohol, Cetearyl Glucoside, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Dimethicone, Dodecane, Ethyl Vanillin, Glycerin, Glyceryl Laurate, Glyceryl Stearate Citrate, Glyceryl Stearate SE, Glyceryl Undecylenate, Glycyrrhiza Glabra (Licorice) Root Extract, Hippophae Rhamnoides Fruit Oil, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Isododecane, Palmitoyl Tetrapeptide-7, Palmitoyl Tripeptide-1, PEG-60 Hydrogenated Castor Oil, PEG-8, Pentylene Glycol, Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Polysorbate 20, Propanediol, Saccharide Isomerate, Sodium Citrate, Sodium Hyaluronate, Tapioca Starch, Titanium Dioxide (CI 77891), Tocopherol, Tridecyl Salicylate, Trimethylsiloxysilicate, Vaccinium Angustifolium (Blueberry) Fruit Extract, Water (Aqua), Xanthan Gum.

Other Information:

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

Questions?

(888) 322 - 2612

Package Labeling:

INGREDIENTS AND APPEARANCE

NAELI TINTED MINERAL MOISTURIZER SUNSCREEN SPF 50, DARK 
zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73670-608
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	180 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARGAN OIL (UNII: 4V59G5UW9X)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SHEA BUTTER (UNII: K49155WL9Y)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CAPRYLYL METHICONE (UNII: Q95M2P1KJL)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CERAMIDE NG (UNII: C04977SRJ5)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CHAMOMILE (UNII: FGL3685T2X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIMETHICONE (UNII: 92RU3N3Y1O)
DODECANE (UNII: 11A386X1QH)
ETHYL VANILLIN (UNII: YC9ST449YJ)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL LAURATE (UNII: Y98611C087)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
GLYCYRRHIZA GLABRA (LICORICE) ROOT POWDER (UNII: 2788Z9758H)
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ISODODECANE (UNII: A8289P68Y2)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PERSEA GRATISSIMA (AVOCADO) OIL (UNII: 6VNO72PFC1)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPANEDIOL (UNII: 5965N8W85T)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
TAPIOCA STARCH (UNII: 24SC3U704I)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TOCOPHEROL (UNII: R0ZB2556P8)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
LOWBUSH BLUEBERRY (UNII: G90PX41VP0)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73670-608-00	1 in 1 BOX	04/04/2025
1		41.4 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/04/2025

Labeler - ALLI LLC (117308980)

Registrant - Pure Source, LLC (080354456)