GLAMTOX ACTIVE DAILY MOISTURIZING SUNSCREEN- homosalate, octinoxate, oxybenzone liquid

GLAMTOX ACTIVE DAILY MOISTURIZING SUNSCREEN by

Drug Labeling and Warnings

GLAMTOX ACTIVE DAILY MOISTURIZING SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Rodial, Ltd., Laleham Healthcare Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

DRUG FACTS

Active Ingredients                              Purpose

Homosalate                                     Sunscreen

Octinoxate                                       Sunscreen

Oxybenzone                                     Sunscreen

PURPOSE

Uses: Helps prevent sunburn

Higher SPF gives more sunburn protection

WARNINGS

WARNINGS

UV exposure from the sun increases the risk of skin cancer, premature skin aging and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen.

WHEN USING

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

ASK DOCTOR

Stop use and ask a doctor if rash or irritation develops and lasts.

For external use only.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact Poison control right away.

DOSAGE & ADMINISTRATION

Directions: Apply (select one: liberally, generously, smoothly, or evenly) before sun exposure and as needed.

Children under 6 months of age ask a doctor

Apply 1-2 pumps on face, under eyes and on the neck after cleansing. Use in the morning as your daily moisturizer. For best results use everyday for at least 6 months.

INDICATIONS & USAGE

Inactive Ingredients:

Water, Ethyl Hexyl Methaxycinnamate, Cyclopentasiloxane, cetearyl ethylhexanoate, octyldodecanon, ethylhexyl palmitate, glycerin, butysprmum parkii (Shea butter), sucrose stearate, 4-methylbenzylidene camphor, cyclohexasiloxane, cetearyl alcohol, stearic acid, butyl methoxybenzoylmethane, polysilicone-11, phenoxyethanol, propylene glycol, dimethicone, benzyl alcohol, caprylic/capric triglyceride, ascorbyl tetraisopalmitate, punica granatum (pomegranate) extract, commiphora mukul resin extract, sodium hyaluronate, acetyl hexapeptide-8, palmitoyl pentapeptide-3, rosa damascena flower oil, citrus aurantium dulcis (orange) flower oil, citrus grandis (grapefruit) peel oil, Limonene, citronellol, geraniol, polyacrylamide, c13-14 isoparaffin xanthan gum,, tocopherol, ethylhexylglycerin, silica dimethyl silylate, butylene glycol, caprylyl glycol, hexylene glycol, carbomer, disodium EDTA, triethanolamine, laureth-7, polysorbate 20

PRINCIPAL DISPLAY PANEL

SPL UNCLASSIFIED SECTION

In the age of chemical peels and cosmetic surgery, Rodial has captured natures power by creating a range of supper effective skincare.

Rodial products help to reduce the appearance of specific skin concerns from wrinkles and age spots to cellulite and stretch marks.

In all Rodial products, pomegranate ellagic tannins, with their natural soothing properties are combined with breakthrough natural ingredients clinically tested to show results.

PRINCIPAL DISPLAY PANEL

SPF 18  

Glamtox

Active Daily  Moisturizing Sunscreen Lotion

with pomegranate ellagic tannin cell protection

1.7 fl. oz. (50 ml)

SPL UNCLASSIFIED SECTION

Rodial Glamtox SPF 18 combines daily hydration with vitamins to help reduce the appearance of wrinkles as a non-invasive alternative to surgery.

SPL UNCLASSIFIED SECTION

Micro-injected hyaluronicspheres, Myrrh extract, and Vitamin C help to reduce the appearance of wrinkes and expression lines. Pomegranate Ellagic Tannins combine with SPF 18 active ingredients to protect and prevent future skin damage.

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

Directions

Apply (select one: liberally, generously, smoothly or evenly) before sun exposure and as needed.

Children under 6 months of age: ask a doctor

Apply 1-2 pumps on face, under eyes and on the neck after cleansing. Use in the morning as your daily moisturizer. for best results, user every day for at least 6 months.

Manufactured for

Rodial Ltd.

London, SW10 0SZ, UK

Made in the UK

www.rodial.co.uk

SPF 18

Glamtox

Active Daily Moisturizing Sunscreen Lotion

with pomegranate ellagic tannin cell protection

1.5 fl oz. (50 ml)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GLAMTOX ACTIVE DAILY MOISTURIZING SUNSCREEN 
homosalate, octinoxate, oxybenzone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52456-018
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	3 mL  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	8 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52456-018-50	1 in 1 BOX
1		50 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/30/2010

Labeler - Rodial, Ltd. (237407262)

Establishment
Name	Address	ID/FEI	Business Operations
Laleham Healthcare Limited		217105741	manufacture