NDC 63550-851 Sun Defense Spf 30

NDC Product Code 63550-851

NDC 63550-851-10

Package Description: 120 mL in 1 BOX

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

NDC Product Information

Sun Defense Spf 30 with NDC 63550-851 is a product labeled by Kamins Dermatologics Inc.. The generic name of Sun Defense Spf 30 is . The product's dosage form is and is administered via form.

Labeler Name: Kamins Dermatologics Inc.

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)
  • OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ACER SACCHARUM SAP (UNII: 75UOH57984)
  • .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • 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: Kamins Dermatologics Inc.
Labeler Code: 63550
Start Marketing Date: 09-02-2011 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: 12-31-2017 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.

Sun Defense Spf 30 Product Label Images

Sun Defense Spf 30 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

Otc - Active Ingredient

Active ingredients:Avobenzone 2.5%Octinoxate 7.5%Oxybenzone 6%Titanium dioxide 2%

Otc - Purpose

Purpose: Sunscreen

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Indications & Usage

This oil and fragrance-free broad spectrum UVA/UVB sunscreen provides important protection against the sun’s harmful rays. Recommended for use on face and body, for everyday wear and outdoor activities. This cosmetically elegant formula is non-greasy, leaves a matte finish, and can be reapplied over makeup.• fragrance-free • oil-free• for face and bodyUses■ Helps prevent sunburn.■ Higher SPF gives more sunburn protection.■ Provides high protection against sunburn.

Warnings

WarningsFor external use only.When using this product, keep out of eyes. If contact occurs, rinse abundantly with water to remove.Stop use and ask a doctor if rash or irritation develops and lasts.If swallowed, seek medical assistance or contact a Poison Control
Center immediately.Other informationSun alert: Limiting sun exposure, wearing protective clothing, and using
sunscreens may reduce the risks of skin aging, skin cancer, and other harmful
effects of the sun.Store at room temperature 15-30°C (59-86°F).

Dosage & Administration

Directions■ Apply liberally and evenly to face and exposed areas 15-30
minutes before sun exposure.

■ Reapply every two hours or as needed. ■ Reapply
after swimming, towel drying, washing or perspiring heavily. ■ Children under 6 months of age: ask a doctor.

Inactive Ingredient

Inactive ingredients: water, octyldodecyl neopentanoate, propylene glycol, acer saccharum, tocopheryl acetate, cetyl alcohol, stearic acid, DEA-cetyl phosphate, panthenol, dimethicone, xanthan gum, carbomer, sodium hydroxide, phenoxyethanol, chlorphenesin, BHT, iron oxides (CI 77491).

* Please review the disclaimer below.