NDC 68078-028 Lip Shine Spf35 Sunscreen

NDC Product Code 68078-028

NDC 68078-028-01

Package Description: 1 TUBE, WITH APPLICATOR in 1 CARTON > 4 mL in 1 TUBE, WITH APPLICATOR

NDC 68078-028-02

Package Description: 1.7 mL in 1 TUBE, WITH APPLICATOR

This product is EXCLUDED from the official NDC directory because the listing certification is expired.

NDC Product Information

Lip Shine Spf35 Sunscreen with NDC 68078-028 is a product labeled by Colorescience. The generic name of Lip Shine Spf35 Sunscreen is . The product's dosage form is and is administered via form.

Labeler Name: Colorescience

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.

  • PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
  • NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • MICA (UNII: V8A1AW0880)
  • ETHYLHEXYL PALMITATE (UNII: 2865993309)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
  • GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3) (UNII: G300307ZXP)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • TRIBEHENIN (UNII: 8OC9U7TQZ0)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
  • SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • STANNIC OXIDE (UNII: KM7N50LOS6)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • CARMINIC ACID (UNII: CID8Z8N95N)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Labeler Information

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

Labeler Name: Colorescience
Labeler Code: 68078
Start Marketing Date: 07-01-2017 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: 12-31-2020 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: E 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.

Lip Shine Spf35 Sunscreen Product Label Images

Lip Shine Spf35 Sunscreen 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

Distributed in USAby Colorescience®Carlsbad, CA 92011

Active Ingredients

Zinc Oxide 6.6%

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 eyes. Rinse with water to remove.

Otc - Stop Use

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

  • Apply liberally 15 minutes before sun exposure. Works best on moisturized skin.Reapply:After 40 minutes of swimming or sweating.Immediately after towel drying.At least every 2 hours.Children under 6 months: ask a doctor.Sun Protection MeasuresSpending 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.

Inactive Ingredients

Phenyl Trimethicone, Bis-Vinyl Dimethicone/ Dimethicone Copolymer, Neopentyl Glycol Diheptanoate, Disteardimonium Hectorite, Mica, Ethylhexyl Palmitate, Tocopheryl Acetate, Triethyl Citrate, Glyceryl Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Polyhydroxystearic Acid, Tribehenin, Sodium Hyaluronate, Palmitoyl Tripeptide-1, Sorbitan Isostearate, Tin Oxide, Flavor/Aroma, Limonene, Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891), Carmine (CI 75470). Contains Carmine as a color additive.

Other Information

Protect this product from excessive heat and direct sun.

* Please review the disclaimer below.