NDC 60541-8407 Octinoxate

NDC Product Code 60541-8407

NDC 60541-8407-4

Package Description: 1 BOTTLE in 1 BOX > 30 mL in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Octinoxate with NDC 60541-8407 is a product labeled by Hayden Caleel Llc. The generic name of Octinoxate is . The product's dosage form is and is administered via form.

Labeler Name: Hayden Caleel Llc

Dosage Form: -

Product Type: 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.

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)
  • ETHYLHEXYL PALMITATE (UNII: 2865993309)
  • NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
  • TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CYCLOMETHICONE 6 (UNII: XHK3U310BA)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
  • OCTYLDODECANOL (UNII: 461N1O614Y)
  • PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
  • ISOHEXADECANE (UNII: 918X1OUF1E)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
  • VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
  • CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Labeler Information

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

Labeler Name: Hayden Caleel Llc
Labeler Code: 60541
Start Marketing Date: 09-01-2013 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: 12-31-2019 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: I 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.

Octinoxate 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

Other

Drug Facts

Active Ingredients

Octinoxate 5%
Titanium Dioxide 10%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only

Otc - Do Not Use

Do not use on damaged or broken skin.

Otc - When Using

When using this product keep out of the eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if skin 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

  • 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 of age: 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 10 a.m. – 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses

Other Information

  • Protect this product from excessive heat and direct sun

Inactive Ingredients

Aqua (Water/Eau), Ethylhexyl Palmitate, Neopentyl Glycol Dicaprylate/Dicaprate, Tridecyl Trimellitate, Silica, Cyclopentasiloxane, Caprylic/Capric Triglyceride, HDI/Trimethylol Hexyllactone Crosspolymer, Butylene Glycol, Glycerin, Polyglyceryl-3 Diisostearate, Cyclohexasiloxane, Octyldodecanol, Octyldecyl Xyloside, PEG-30 Dipolyhydroxystearate, Silica Dimethyl Silylate, Phenoxyethanol, Hydroxyethylacrylate/Sodium Acryloydimethyl Taurate Copolymer, Isohexadecane, Polysorbate 60, Caprylyl Glycol, Ethylhexyl Glycerin, Tetrahexyldecyl Ascorbate (Vitamin C), Tocopheryl Acetate (Vitamin E), Polymethylsilsesquioxane, Dimethicone, Retinyl Palmitate (Vitamin A), Triethoxycaprylylsilane, Camellia Oleifera (Green Tea) Leaf Extract, Diamond Powder, (+/-):Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

* Please review the disclaimer below.