Label: TECHNIBLOCK ULTRA SUNSCREEN- avobenzone,octinoxate,oxybenzone,padimate lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 49672-100-01 - Packager: The Myles Group 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 September 29, 2010
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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WARNINGS
Warnings:
• For External Use Only
• Extremely Flammable: keep away from fire or flame
Contents under pressure. Do not puncture or incinerate.
Do not store at temperature above 120°F.
• UV exposure from the sun increases the risk of skin cancer,
premature skin ageing, and other skin damage. It is important
to decrease UV exposure by limiting time in the sun, wearing
protective clothing, and using a sunscreen.
• Keep out of eyes. Rinse with water to remove.-Stop use and ask a doctor if skin rash occurs
-Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
• Contents under pressure. Do not puncture or incenerate. Do not store at temperatures above 120F
• Avoid contact with painted and synthetic surfaces.
• Spray in a well ventilated area and avoid inhalation.
- WHEN USING
- STOP USE
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
- STORAGE AND HANDLING
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DOSAGE & ADMINISTRATION
• Apply evenly before sun exposure as needed.• Hold can about 6 inches away from body and spray onto
skin. Use hand to spread evenly.
• Do not spray directly onto face - spray into palm and
smooth over face and neck.
• Children under 6 months of age - ask a doctor.
• Reapply as needed or after towel drying, swimming or
perspiring.
- INACTIVE INGREDIENT
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DESCRIPTION
See base of tin for batch details
This product has a security tab on either side of the
dust cover. Do not use if these tabs are broken,
missing or have been tampered with.
Manufactured by:
Technikon Laboratories (Ply) Ltd P .0 . Box 1 5 0, Maraisburg, 1700, RSA
Distributed By:
The Myles Group LLC 4433 MountainRd , Ste#3 Pasadena, MD 21122
Tel: (443) 305-2304, PRODUCT OF SOUTH AFRICA
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TECHNIBLOCK ULTRA SUNSCREEN
avobenzone,octinoxate,oxybenzone,padimate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49672-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.6 mL in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6.3 mL in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 3.4 mL in 100 mL PADIMATE A (UNII: 77FU10423X) (PADIMATE A - UNII:77FU10423X) PADIMATE A 5.1 mL in 100 mL Inactive Ingredients Ingredient Name Strength BUTANE (UNII: 6LV4FOR43R) ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) OCTYLDODECANOL (UNII: 461N1O614Y) PROPANE (UNII: T75W9911L6) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49672-100-01 125 mL in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/05/2010 Labeler - The Myles Group LLC (831442905) Establishment Name Address ID/FEI Business Operations Technikon Laboratories Pty Ltd. 636974573 manufacture
