TECHNIBLOCK ULTRA SUNSCREEN- avobenzone,octinoxate,oxybenzone,padimate lotion

TECHNIblock ULTRA SUNSCREEN by

Drug Labeling and Warnings

TECHNIblock ULTRA SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by The Myles Group LLC, Technikon Laboratories Pty Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts:

Active Ingredients:               Purpose

Avobenzone 0.5%                 Sunscreen

Octinoxate 6.3%                     Sunscreen

Oxybenzone 3.4%                  Sunscreen

Padimate 5.1%                        Sunscreen

INDICATIONS & USAGE

Uses:

Helps prevent Sunburn

Higher SPF gives more sunburn protection.

Provides moderate protection against sunburn.

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

Keep out of eyes. Rinse with water
to remove.

STOP USE

Stop use and ask a doctor if skin rash occurs.

ASK DOCTOR

Stop use and ask a doctor if skin rash occurs.

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.

STORAGE AND HANDLING

Contents under pressure. Do not puncture or incenerate. Do
not store at temperature above 120°F.

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

Butane, Ethyl Alcohol, Glycerin, Octyldodecanol, Propane,
Water.

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

NDC49672-100-01

TECHNIblock

ULTRA SUNSCREEN

SPF

30+

WATER RESISTANT

NON-GREASY

BROAD SPECTRUM

UVB/UVA

PROTECTION

4.17 fl oz

(125 mL)

www.SubBlockerUSA.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TECHNIBLOCK ULTRA SUNSCREEN 
avobenzone,octinoxate,oxybenzone,padimate lotion

Product 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