MOISTURIZER- avobenzone 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]

Ative ingredients

Avobenzone 3.0%. Hosmosalate 10.0%. Octisalate 5.0%. Octocrylene 1.0%. Oxybenzone 5.0%

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 again caused by the sun

Warnings

For external use only

Do not use

Do not use on damage 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 swallowed, get medical help or contact a Poison Control Center rigth away

Directions

For sunscreen use: apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours.

Sun protections measures. Spending time in the sun increasses your risk of skin cancer and early skin aging. To decrease this risk, regulary 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 a.m - 2 p.m. Wear long - sleeved shirts, pants, hats, and sunglasses. Children under 6 months of age: Ask a doctor.

Other information

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

Inactive ingredients

Water, Butylene Glycol, Glyceryl Stearate, Cetearyl Alcohol, Glycerin, Potassium Cetyl Phosphate, Stearic Acid, Oligopeptide-24, Polysorbate 60, Polyester-8, Sclerotium gum, Bisabolol, Phenoxyethanol, Dimethicone, Sodium PCA, Squalane, Tocopheryl Acetate, Helianthus Annuus (Sunflower) Seed Oil, Persea Gratissima (Avocado) Oil, Allantoin, Caprylyl Glycol, Phytosterols, Chlorphenesin, Olea Europaea (Olive) Fruit Oil, Disodium EDTA, Glycolipids, Sodium Hyaluronate, Citrus Aurantium Dulcis (Orange) Oil, Zingiber Officinale (Ginger) Root Extract, Tocopherol, Citral, Linalool, Limonene.

Package label principal display panel

Package label principal display panel

INGREDIENTS AND APPEARANCE

MOISTURIZER 
avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61354-041
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)	1.2 g  in 100 g
SQUALANE (UNII: GW89575KF9)	0.5 g  in 100 g
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)	1.75 g  in 100 g
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)	3 g  in 100 g
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)	1 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	0.99 g  in 100 g
LEVOMENOL (UNII: 24WE03BX2T)	0.64 g  in 100 g
WATER (UNII: 059QF0KO0R)	59.89 g  in 100 g
STEARIC ACID (UNII: 4ELV7Z65AP)	1 g  in 100 g
BETASIZOFIRAN (UNII: 2X51AD1X3T)	0.7 g  in 100 g
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.64 g  in 100 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.5 g  in 100 g
DIMETHICONE (UNII: 92RU3N3Y1O)	0.5 g  in 100 g
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)	0.75 g  in 100 g
POLYSORBATE 60 (UNII: CAL22UVI4M)	0.8 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61354-041-02	1 in 1 CARTON	01/04/2022
1	NDC: 61354-041-01	100 g in 1 JAR; 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(61354-041)