FOUNDATION- octinoxate emulsion 
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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PUR 4-IN-1 LIQUID 14-HOUR WEAR FOUNDATION BROAD SPECTRUM SPF 15 BLUSH MEDIUM

Medicinal Ingredient / Active Ingredient

Octinoxate 5.0% w/w

Purpose

Sunscreen

Uses

Helps prevent sunburn.

Warnings

For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove.

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

Directions

Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating.
Reapply at least every 2 hours. Children under 6 months: ask a doctor.
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease 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 10am to 2 pm
Wear long-sleeved shirts, pants, hats, and sunglasses

Other

Protect this product from excessive heat and direct sun.
In the unlikely event of an adverse reaction, please contact 1.866.PUR.0022.

Non-medicinal Ingredients / Inactive Ingredients

Aqua, Cyclopentasiloxane, Propanediol, Sodium PCA, Cetyl PEG/PPG-10/1 Dimethicone,Trimethylsiloxysilicate, Boron Nitride, Dimethicone/Vinyl Dimethicone Crosspolymer, C12-15 Alkyl Ethylhexanoate, Magnesium Sulfate, Silica Silylate, Zinc Stearate, Phenoxyethanol, Mannitol, Bis-PEG/PPG-14/14 Dimethicone, Laureth-7, Amodimethicone, Lecithin, Tribehenin, Butyrospermum Parkii (Shea) Butter Extract, Sodium Starch Octenylsuccinate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Disteardimonium Hectorite, Glucosamine HCl, Trihydroxystearin, Dimethiconol, Triethoxycaprylylsilane, Pisum Sativum (Pea) Extract, Xanthan Gum, Bambusa Vulgaris Leaf/Stem Extract, Hydroxyethylcellulose, Tocopheryl Acetate, Ethylhexylglycerin, Propylene Carbonate, Sodium Gluconate, Pentylene Glycol, Lactic Acid, Citric Acid, Sodium Citrate, Dextrin, Retinol, Waltheria Indica Leaf Extract, Ferulic Acid, EDTA, Ceramide AP, May Contain: Mica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499).

Primary packaging

61354-040_AW61354-040_AW

Secondary Packaging

61354-040-02_AW61354-040-03_AW61354-040-03_AW

FOUNDATION 
octinoxate emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61354-040
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4.9965 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
STARCH, CORN (UNII: O8232NY3SJ)  
WATER (UNII: 059QF0KO0R)  
C12-15 ALKYL ETHYLHEXANOATE (UNII: GQJ580CH83)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PROPANEDIOL (UNII: 5965N8W85T)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
DIMETHICONE/DIVINYLDIMETHICONE/SILSESQUIOXANE CROSSPOLYMER (UNII: T3064TZ75A)  
MANNITOL (UNII: 3OWL53L36A)  
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
MICA (UNII: V8A1AW0880)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
ZINC STEARATE (UNII: H92E6QA4FV)  
LAURETH-7 (UNII: Z95S6G8201)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61354-040-021 in 1 CARTON02/23/202102/10/2023
127 mg in 1 BOTTLE, GLASS; 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(61354-040)

Revised: 2/2023
Document Id: f45d2f79-ec5f-9e7f-e053-2995a90a48fa
Set id: bc074bef-b7ff-f460-e053-2a95a90a854c
Version: 2
Effective Time: 20230210
 
Oxygen Development LLC