NAELI DAY MOISTURIZER SPF 30- octisalate, octocrylene, avobenzone lotion

NAELI Day Moisturizer SPF 30 by

Drug Labeling and Warnings

NAELI Day Moisturizer SPF 30 by is a Otc medication manufactured, distributed, or labeled by Alli LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredients

Octisalate 5.00%

Octocrylene 5.00%

Avobenzone 3.00%

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 the risk, regularly use a sunscreen with 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:

Aqua (Deionized Water), Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Cetearyl Glucoside, Saccharide Isomerate, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Argania Spinosa (Argan) Oil, Isostearyl Palmitate, Mangifera Indica (Mango) Butter, Tocopheryl Acetate (Vitamin E), Camellia Sinensis (Green Tea) Extract, Hydrolyzed Oat Protein, Glycerin, Butylene Glycol, Carbomer, Polysorbate 20, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Hyaluronic Acid, Butyrospermum Parkii (Shea) Butter, Hydrolyzed Collagen, Punica Granatum (Pomegranate) Extract, Tetrahexyldecyl Ascorbate (Vitamin C), Centella Asiatica (Gotu Kola) Extract, Retinyl Palmitate (Vitamin A), Theobroma Cacao (Cocoa) Butter, a-Lipoic Acid, Allantoin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium PCA, Ceramide NG, Lavandula Angustifolia (Lavender) Oil, Cocos Nucifera (Coconut) Oil, Sodium Hydroxide, Glyceryl Caprylate, Glyceryl Undecylenate.

Other Information:

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

Package Labeling:

INGREDIENTS AND APPEARANCE

NAELI DAY MOISTURIZER SPF 30 
octisalate, octocrylene, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73670-049
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
ARGAN OIL (UNII: 4V59G5UW9X)
ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1)
MANGO (UNII: I629I3NR86)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
HYALURONIC ACID (UNII: S270N0TRQY)
SHEA BUTTER (UNII: K49155WL9Y)
POMEGRANATE (UNII: 56687D1Z4D)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
COCOA (UNII: D9108TZ9KG)
ALLANTOIN (UNII: 344S277G0Z)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
CERAMIDE NG (UNII: C04977SRJ5)
LAVENDER OIL (UNII: ZBP1YXW0H8)
COCONUT OIL (UNII: Q9L0O73W7L)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73670-049-00	1 in 1 CARTON	03/10/2020
1		40 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 not final	part352	03/10/2020

Labeler - Alli LLC (117308980)