Label: FOUNDATION- octinoxate emulsion
- NDC Code(s): 61354-040-02
- Packager: Oxygen Development LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 10, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Medicinal Ingredient / Active Ingredient
- Purpose
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
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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
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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
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INGREDIENTS AND APPEARANCE
FOUNDATION
octinoxate emulsionProduct 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:61354-040-02 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)
