MOISTURIZER- avobenzone, oxybenzone, octisalate, homosalate, octocrylene 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%

Homosalate 10%

Octisalate 5%

Octcrylene 1%

Oxygenzone 5%

Purpose: Sunscreen

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

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 swallowed, get medical help or contact a poison control center right 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 Protection Measures

Spending time in the sun increased your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF valuye of 15 or higher and other sun protection measures inclusing:

• limit time in the sun, specially from 10am - 2pm
• 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, squalana, tocopheryl acetate, helianthus annus (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 - primary

package label - secondary

INGREDIENTS AND APPEARANCE

MOISTURIZER 
avobenzone, oxybenzone, octisalate, homosalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61354-035
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
SQUALANE (UNII: GW89575KF9)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
SUNFLOWER OIL (UNII: 3W1JG795YI)
POLYSORBATE 60 (UNII: CAL22UVI4M)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
GLYCERIN (UNII: PDC6A3C0OX)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61354-035-08	1 in 1 CARTON	02/22/2021
1	NDC: 61354-035-04	50 mg 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	02/22/2021

Labeler - Oxygen Development LLC (137098492)

Establishment
Name	Address	ID/FEI	Business Operations
Oxygen Development LLC		137098492	manufacture(61354-035)