Cream by Oxygen Development LLC CREAM- zinc oxide cream

Cream by

Drug Labeling and Warnings

Cream 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 22.4%

Purpose

Sunscreen

Uses

Help prevent sunburn.

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin agung caused by the sun.

Warnings

For external use only.

Do not use

Do not use on damaged or broken skin.

When using this product

When using this product keep out of eyes.

Rinse with water to remove.

Stop use and ask a doctor

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 water resistant sunscreen if swimming or sweating.

Reapply at least every 2 hours.

Sun protection measures:

Spending time in the sun increases 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 10 am-2 pm.

-wear long-sleeved shirts, pants, hats and sunglasses.

-children under 6 months of age: Ask a doctor.

Other information

Protect 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 Malus (Apple) Fruit Extract, Coco-Glucoside, Lactobacillus Ferment, Rubus Idaeus (Raspberry) Seed Oil, Cocos Nucifera (Coconut) Liquid Endosperm, Curcuma Longa (Turmeric) Rhizomes Oil, Butyrospermum Parkii Nut Extract, Hydrolyzed Jojoba Esters, Tocopherol, Dipotassium Glycyrrhizinate, 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, Glucoside, Sclerotium Gum, Cetearyl Glucoside, Ethylhexylglycerin, Xanthan Gum, Octyldodecanol, Tapioca Starch, Citric Acid, Sorbitan Oleate, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate, May contain +/- Iron Oxides (CI 77491, CI 77492) *Certified Organic.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CREAM 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61354-115
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	21.76 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)	0.96 mg  in 100 mg
WATER (UNII: 059QF0KO0R)	36.09 mg  in 100 mg
APPLE (UNII: B423VGH5S9)	1.5 mg  in 100 mg
COCO GLUCOSIDE (UNII: ICS790225B)	1.05 mg  in 100 mg
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)	0.96 mg  in 100 mg
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)	0.96 mg  in 100 mg
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)	16.85 mg  in 100 mg
COCONUT ALKANES (UNII: 1E5KJY107T)	4.7 mg  in 100 mg
RASPBERRY SEED OIL (UNII: 9S8867952A)	0.49 mg  in 100 mg
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.9 mg  in 100 mg
LACTOBACILLUS REUTERI F275 STRAIN (UNII: 3K209OP33H)	0.99 mg  in 100 mg
GLYCERIN (UNII: PDC6A3C0OX)	4.79 mg  in 100 mg
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)	4.22 mg  in 100 mg
ISOSTEARIC ACID (UNII: X33R8U0062)	0.96 mg  in 100 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61354-115-02	1 in 1 CARTON	10/26/2023
1	NDC: 61354-115-01	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 Drug	M020	10/26/2023

Labeler - Oxygen Development LLC (137098492)

Establishment
Name	Address	ID/FEI	Business Operations
Oxygen Development LLC		137098492	manufacture(61354-115)