CLARANT B3- avobenzone octinoxate cream

Clarant B3 by

Drug Labeling and Warnings

Clarant B3 by is a Otc medication manufactured, distributed, or labeled by ALL NATURAL DYNAMICS, Unilever Manufacturera, S. de R.L. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone
Octinoxate

Active Ingredients: (Each 100 g contains:) Purpose

Avobenzone 2.8 g           Sunscreen
Octinoxate 7.1 g              Sunscreen

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging

For external use only

Uses

helps prevent sunburn

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove

Stop use and ask a doctor

if rash occurs

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Inactive ingredients:

Water, Niacinamide, Stearic Acid, Isopropyl Myristate, Mineral Oil, Glyceryl Stearate, Glycerin, Triethanolamine, Sodium Ascorbyl Phosphate, Propylparaben,Disodium EDTA, Sodium Ascorbyl Phosphate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLARANT B3 
avobenzone octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51769-614
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	Avobenzone	2800 mg  in 100 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	7100 mg  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Niacinamide (UNII: 25X51I8RD4)
Stearic Acid (UNII: 4ELV7Z65AP)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
Mineral Oil (UNII: T5L8T28FGP)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Glycerin (UNII: PDC6A3C0OX)
Trolamine (UNII: 9O3K93S3TK)
Propylparaben (UNII: Z8IX2SC1OH)
Edetate Disodium (UNII: 7FLD91C86K)
Sodium Ascorbyl Phosphate (UNII: 836SJG51DR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51769-614-40	400 g in 1 JAR	07/04/2014
2	NDC: 51769-614-20	200 g in 1 JAR	07/04/2014
3	NDC: 51769-614-10	100 g in 1 JAR	07/04/2014
4	NDC: 51769-614-05	50 g in 1 JAR	07/04/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/04/2014

Labeler - ALL NATURAL DYNAMICS (962732892)

Establishment
Name	Address	ID/FEI	Business Operations
Unilever Manufacturera, S. de R.L. de C.V.		812625062	manufacture(51769-614)