FOUNDATION- octinoxate emulsion

Foundation by

Drug Labeling and Warnings

Foundation by is a Otc medication manufactured, distributed, or labeled by Oxygen Development LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

Secondary Packaging

INGREDIENTS AND APPEARANCE

FOUNDATION 
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61354-040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4.9965 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61354-040-04	1 in 1 CARTON	02/23/2021	02/10/2023
1		27 mg in 1 BOTTLE, GLASS; 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	02/23/2021

Labeler - Oxygen Development LLC (137098492)

Establishment
Name	Address	ID/FEI	Business Operations
Oxygen Development LLC		137098492	manufacture(61354-040)