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]

Active ingredients

Avobenzone 3.0%, Octinoxate 7.29%, Octocrylene 3.0%, Oxybenzone 2.0%

Uses

Helps prevent sunburn

If used as directed with other sun protections 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

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

Stop use

Stop use and ask a doctor if rash occurs

Keep out of reach of children

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

Directions

For sunscree use: apply liberally 15 minutes 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 increases your risk of skin cancer and early skin again. To decrease this risk, regulary use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: lomit time in the sun, especially from 10 a.m - 2 p.m. wear long - sleeve shirts, pants, hats, and sunglasses. Children unther 6 months: ask a doctor.

Other information

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MOISTURIZER 
avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61354-039
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.29 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	4.98 g  in 100 g
XANTHAN GUM (UNII: TTV12P4NEE)	0.2 g  in 100 g
WATER (UNII: 059QF0KO0R)	72.61 g  in 100 g
ISOHEXADECANE (UNII: 918X1OUF1E)	4.56 g  in 100 g
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.9 g  in 100 g
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)	0.93 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61354-039-02	1 in 1 CARTON	01/03/2022
1	NDC: 61354-039-01	100 g 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	01/03/2022

Labeler - Oxygen Development LLC (137098492)

Establishment
Name	Address	ID/FEI	Business Operations
Oxygen Development LLC		137098492	manufacture(61354-039)