MOISTURIZER- zinc oxide cream

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 Ingredients

Zinc Oxide 22.40%

Purpose

Sunscreen

Uses

• Helps prevent sunburn.
• 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 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 occurs.

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

Directions

• Apply liberally 15 minutes before sun exposure.
• Use a water resistant sunscreen if swimming or sweating.
• Reapply at least every 2 hours.
• Sun Protection Measures: Spending time in the sun increases your risk of skin cancer an early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10am-2pm
• wear long-sleeved shirts, pants hats and sunglasses
• Children under 6 months of age: Ask a doctor.

Other Information

Proect this product from excessive heat and direct sun.

Inactive ingredients

Water(Aqua), Caprylic/Capric Triglyceride, Coconut Alkanes, Cetearyl Alcohol, Glycerin, Aloe Barbadensis Leaf Juice, Pyrus Males (Apple) Fruit Extract, Coco-Glucoside, Lactobacillus Ferment, Rubus Idaeus(red Raspberry) Seed oil, Cocos Nucifera(Coconut) Liquid Endosperm, Curcuma Longa (Turmeric) Rhizomes Oil, Butyrospermum parkii nut Extract, Hydrolyzed Jojoba Esters, Tocopherol, Dipotassium Glycyrrhizate, Vanilla Planifolia Fruit Extract, Glycyrrhiza Glabra(Licorice) Root Extract, Butylene Glycol, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Coco-Caprylate/Caprate, Caprylyl/Capryl Glucoside, Sclerotium Gum, Cetearyl Glucoside, Ethylhexylglycerin, Xantham Gum, Octyldodecanol, Tapioca Startch, Citric Acid, Sorbitan Oleate, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate, May contain +/- Iron Oxides (CI 77491, CI 77492).

Questions or comments?

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MOISTURIZER 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61354-048(NDC:61354-012)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	22.4 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
COCONUT ALKANES (UNII: 1E5KJY107T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
APPLE (UNII: B423VGH5S9)
COCO GLUCOSIDE (UNII: ICS790225B)
LACTOBACILLUS REUTERI (UNII: 9913I24QEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61354-048-01	7.5 mg in 1 BOTTLE; Type 0: Not a Combination Product	04/29/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/29/2022

Labeler - OXYGEN DEVELOPMENT, LLC (137098492)

Establishment
Name	Address	ID/FEI	Business Operations
OXYGEN DEVELOPMENT, LLC		137098492	repack(61354-048) , manufacture(61354-048)