NDC 72782-101 Yensa Bc Foundation Spf 40

Octinoxate, Titanium Dioxide, Zinc Oxide

NDC Product Code 72782-101

NDC Product Information

Yensa Bc Foundation Spf 40 with NDC 72782-101 is a a human over the counter drug product labeled by Yensa Llc. The generic name of Yensa Bc Foundation Spf 40 is octinoxate, titanium dioxide, zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Yensa Llc

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Yensa Bc Foundation Spf 40 Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • OCTINOXATE 7.4 g/100mL
  • TITANIUM DIOXIDE 9.4 g/100mL
  • ZINC OXIDE 7 g/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • CYCLOMETHICONE 6 (UNII: XHK3U310BA)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)
  • SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
  • ETHYLHEXYL PALMITATE (UNII: 2865993309)
  • ARBUTIN (UNII: C5INA23HXF)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
  • MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
  • CERESIN (UNII: Q1LS2UJO3A)
  • PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
  • ARONIA MELANOCARPA FRUIT (UNII: S935718Z2Q)
  • SESAME SEED (UNII: 7Y1255HVXR)
  • NIGELLA SATIVA SEED (UNII: 4LVZ0Z0ITT)
  • BLACKBERRY (UNII: 8A6OMU3I8L)
  • RICE GERM (UNII: 7N2B70SFEZ)
  • UNDARIA PINNATIFIDA (UNII: ICV1OK7M1S)
  • LAMINARIA JAPONICA (UNII: WE98HW412B)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • ADENOSINE (UNII: K72T3FS567)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • BERGAMOT OIL (UNII: 39W1PKE3JI)
  • SESAME OIL (UNII: QX10HYY4QV)
  • LENTINULA EDODES MYCELIUM (UNII: CU2S39TB8O)
  • URTICA DIOICA LEAF (UNII: X6M0DRN46Q)
  • SALVIA HISPANICA SEED (UNII: NU0OLX06F8)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • CANANGA OIL (UNII: 8YOY78GNNX)
  • PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
  • ORANGE OIL (UNII: AKN3KSD11B)
  • PALMAROSA OIL (UNII: 0J3G3O53ST)
  • MAGNOLIA X ALBA FLOWER OIL (UNII: 8QDN200R1S)
  • CLOVE LEAF OIL (UNII: VCA5491KVF)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
  • LINALOOL, (+)- (UNII: F4VNO44C09)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Yensa Llc
Labeler Code: 72782
FDA Application Number: part352 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 01-29-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Yensa Bc Foundation Spf 40 Product Label Images

Yensa Bc Foundation Spf 40 Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

OCTINOXATE 7.4%TITANIUM DIOXIDE 9.4%ZINC OXIDE 7.0%

Purpose

SUNSCREEN

Use

USE HELPS PREVENT SUNBURN

Warnings

FOR EXTERNAL USE ONLY.DO NOT USE ON DAMAGED OR BROKEN SKIN.WHEN USING THIS PRODUCTKEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.STOP USE AND ASK A DOCTOR IF RASH OCCURS

Otc - 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

  • FOR SUNSCREEN USE:APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.REAPPLY AT LEAST EVERY 2 HOURS.USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.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 10 A.M. TO 2 P.M.   WEAR LONG-SLEEVED SHIRTS, PANTS, HATS AND SUNGLASSESCHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR

Other Information

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN LIGHT.

Inactive Ingredients

WATER, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, CAPRYLIC/CAPRIC TRIGLYCERIDE, BUTYLENE GLYCOL, CETYL PEG/PPG-10/1 DIMETHICONE, SORBITAN SESQUIOLEATE, ETHYLHEXYL PALMITATE, ARBUTIN, DIMETHICONE, SODIUM CHLORIDE, BEESWAX, STEARALKONIUM HECTORITE, MAGNESIUM ALUMINUM SILICATE, PHENOXYETHANOL, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, OZOKERITE, PEG-10 DIMETHICONE CROSSPOLYMER, ARONIA MELANOCARPA FRUIT EXTRACT, SESAMUM INDICUM (SESAME) SEED EXTRACT, NIGELLA SATIVA SEED EXTRACT, RUBUS FRUTICOSUS (BLACKBERRY) FRUIT EXTRACT, ORYZA SATIVA (RICE) EXTRACT, UNDARIA PINNATIFIDA EXTRACT, LAMINARIA JAPONICA EXTRACT, CAMELIA SINENSIS LEAF EXTRACT, ADENOSINE, OLEA EUROPAEA (OLIVE) FRUIT OIL, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL, SESAMUM INDICUM (SESAME) SEED OIL, LENTINUS EDODES EXTRACT, URTICA DIOICA (NETTLE) EXTRACT, SALVIA HISPANICA SEED EXTRACT, LAVENDULA ANGUSTIFOLIA (LAVENDER) OIL, CANAGA ODORATA FLOWER OIL, PELARGONIUM GRAVEOLENS FLOWER OIL, CITRUS AURANTIUM DULCIS (ORANGE) OIL, CYMBOPOGON MARTINI OIL, MICHELIA ALBA FLOWER OIL, EUGENIA CARYOPHYLLUS (CLOVE) LEAF OIL, EUCALYPTUS GLOBULUS LEAF OIL, 1,2-HEXANEDIOL, JASMINUM OFFICINALE (JASMINE) OIL, SODIUM HYALURONATE, ETHYLHEXYLGLYCERIN, ACETYL HEXAPEPTIDE-8, LINALOOL, LIMONENEMAY CONTAIN:  IRON OXIDES (CI 77491/77492/77499)

* Please review the disclaimer below.