MOISTURIZER- avobenzone, oxybenzone, octisalate, homosalate, octocrylene cream 
OXYGEN DEVELOPMENT, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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PERFECTIF EVEN SKIN TONE CREAM REVIVE DARK SPOT CORRECTOR SPF 30

Active Ingredients

Avobenzone 3.00%, Homosalate 10.00%, Octisalate 5.00%, Octocrylene 1.00%,Oxybenzone 5.00%.

Purpose

Sunscreen

Uses

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

Stop use and ask a doctor if rash occurs.

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Posion Contorl Center right away.

Directions

Other Information

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

Inactive Ingredients

Water, Glyceryl Stearate, Glycerin, Propanediol, C12-15
Alkyl Benzoate, Cetearyl Alcohol, Stearic Acid, Butylene Glycol, Dimethicone, Polyester-8,
Polysorbate 60, Potassium Cetyl Phosphate, Helianthus Annuus (Sunflower) Seed Oil,
Oligopeptide-68, Oligopeptide-24, Phenoxyethanol, Sclerotium Gum, Phenylethyl
Resorcinol, Dimethiconol, Mica, Caprylyl Glycol, Chlorphenesin, Allantoin, Sodium PCA,
Tocopheryl Acetate, Disodium EDTA, Sodium Hydroxide, Glycine Soja (Soybean) Oil,
Hydrogenated Lecithin, Sodium Oleate, Citrus Aurantium Dulcis (Orange) Oil, Tocopherol,
Citral, Limonene, Linalool. May Contain: Titanium Dioxide, Iron Oxides.

Primary package

61354-030-06_AW50ml, 61354-031-01

Secondary package

61354-030-06_AW50ml, 61354-031-01

MOISTURIZER 
avobenzone, oxybenzone, octisalate, homosalate, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61354-031
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 100 mg
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mg  in 100 mg
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 mg  in 100 mg
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 mg  in 100 mg
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SQUALANE (UNII: GW89575KF9)  
PHENYLETHYL RESORCINOL (UNII: G37UFG162O)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
PROPANEDIOL (UNII: 5965N8W85T)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
BETASIZOFIRAN (UNII: 2X51AD1X3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61354-031-011 in 1 CARTON02/23/2021
150 mg in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/23/2021
Labeler - OXYGEN DEVELOPMENT, LLC (137098492)
Establishment
NameAddressID/FEIBusiness Operations
OXYGEN DEVELOPMENT, LLC137098492manufacture(61354-031)

Revised: 2/2023
Document Id: f45d4373-f5c0-a720-e053-2a95a90ac957
Set id: bc03491d-14a1-bd0c-e053-2995a90a1355
Version: 3
Effective Time: 20230210
 
OXYGEN DEVELOPMENT, LLC