MOISTURIZER- zinc oxide lotion

Moisturizer by

Drug Labeling and Warnings

Moisturizer by is a Otc medication manufactured, distributed, or labeled by Oxygen Development LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Zinc Oxide 17%

Purpose

Sunscreen

Uses

helps prevent sunburn protection. 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.

Do not use

Do not use on damage or broken skin.

When using

When using this product keep out of eyes. Rinse with water to remove.

Stop use

Stop use and ask a dosctor if rash occurs.

Keep out the reach of children

​Keep out the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply generously and evenly 15 minutes before sun exposure.

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 thsi risk, regulary use a sunscreen with a Board Spectrum SPF value 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

Other information

Protect the protect in this container from excessive heat and direct sun

Inactive ingredients

Water, Caprylic/Capric Triglyceride, Coco-Caprylate/Caprate, Cetearyl Olivate, Glyceryl Stearate Citrate, Stearyl/Octyldodecyl Citrate Crosspolymer, Dimethicone, Camellia Japonica Seed Oil, Glycolipids, Trehalose, Pullulan, Agastache Mexicana Flower/Leaf/Stem Extract, Camellia Oleifera Leaf Extract, Glycine, Alanine, Serine, Threonine, Chamomilla Recutita (Matricaria) Flower Extract, Leuconostoc/Radish Root Ferment Filtrate, Polylysine, Lecithin, Isostearic Acid, Polyglyceryl-3 Polyricinoleate, Hydrogenated Lecithin, Silica, Xanthan Gum, Cetearyl Alcohol, Tocopheryl Acetate, Mica, Tocopheryl, Sclerotium Gum, Glycerin, Caprylhydroxamic Acid, Titanium Dioxide (CI 77891) (090-50132-000)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MOISTURIZER 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61354-042
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	17.68 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)	5 mg  in 100 mg
SORBITAN OLIVATE (UNII: MDL271E3GR)	1.52 mg  in 100 mg
POLYGLYCERYL-3 STEARATE (UNII: 8FDA8C98S3)	1.2 mg  in 100 mg
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)	0.6 mg  in 100 mg
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)	0.51 mg  in 100 mg
DIMETHICONE (UNII: 92RU3N3Y1O)	1 mg  in 100 mg
ISOSTEARIC ACID (UNII: X33R8U0062)	0.78 mg  in 100 mg
PROPANEDIOL (UNII: 5965N8W85T)	1.6 mg  in 100 mg
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)	0.78 mg  in 100 mg
GLYCERIN (UNII: PDC6A3C0OX)	0.65 mg  in 100 mg
WATER (UNII: 059QF0KO0R)	51.72 mg  in 100 mg
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)	5.2 mg  in 100 mg
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK)	2 mg  in 100 mg
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)	1.78 mg  in 100 mg
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)	2.19 mg  in 100 mg
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)	0.88 mg  in 100 mg
CETEARYL OLIVATE (UNII: 58B69Q84JO)	2.28 mg  in 100 mg
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)	1.12 mg  in 100 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61354-042-02	1 in 1 CARTON	01/04/2022
1	NDC: 61354-042-01	100 mg 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 final	part352	01/04/2022

Labeler - Oxygen Development LLC (137098492)

Establishment
Name	Address	ID/FEI	Business Operations
Oxygen Development LLC		137098492	manufacture(61354-042)