ADVANCED REVITAL- avobenzone, homosalate, octocrylene lotion

Advanced Revital by

Drug Labeling and Warnings

Advanced Revital by is a Otc medication manufactured, distributed, or labeled by Melaleuca, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients
Avobenzone 1.8%, Homosalate 6%, Octisalate 3%, Octocrylene 1.86%, Oxybenzone 1.8%

PURPOSE

Purpose
Sunscreen

INDICATIONS & USAGE

Use

• provides moderate protection against sunburn
  

WARNINGS

Warnings
For external use only

WHEN USING

When using this product

• keep out of eyes. Rinse with water to remove.
  

STOP USE

Stop use and ask a doctor if

• rash or irritation develops and lasts
  

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.

DOSAGE & ADMINISTRATION

Directions

• apply smoothly on cleansed skin before sun exposure and as needed
• children under six months of age: ask a doctor
  

CLINICAL STUDIES

Other information

• dermatologist and allergy tested
  

GENERAL PRECAUTIONS

• Sun 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
• may stain some fabrics
  

STORAGE AND HANDLING

• do not store at temperatures below 32°F (0°C) or above 120°F (49°C)
  

INACTIVE INGREDIENT

Inactive ingredients
aqua (water/eau), polyacrylate-15, polyacrylate-17, C20-22 alkyl phosphate, C20-22 alcohols, trisiloxane, dimethicone, cyclopentasiloxane, dimethicone crosspolymer, cetyl palmitate, glycerin, butyrospermum parkii (shea butter), C12-15 alkyl benzoate, dicaprylyl carbonate, C14-22 alcohols, C12-20 alkyl glucoside, propylheptyl caprylate, acetyl tetrapeptide-9, phenoxyethanol, cetyl alcohol, caprylyl glycol, 1,2 hexanediol, triethanolamine, xanthan gum, trisodium ethylenediamine disuccinate, parfum, bisabolol, panax ginseng root extract, lycium barbarum fruit extract, aloe barbadensis leaf juice, camellia oleifera leaf extract, butylene glycol, allantoin, tocopheryl acetate, limonene, butylphenyl methylpropional

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ADVANCED REVITAL 
avobenzone, homosalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54473-277
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.9 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	3 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.93 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNOSINE (UNII: 8HO6PVN24W)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
ZINC PIDOLATE (UNII: C32PQ86DH4)
SAPINDUS MUKOROSSI FRUIT RIND (UNII: 3D1P12PN9U)
NIACINAMIDE (UNII: 25X51I8RD4)
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)
TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)
UBIDECARENONE (UNII: EJ27X76M46)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LEVOMENOL (UNII: 24WE03BX2T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
TETRAPEPTIDE-21 (UNII: 179JUC43HU)
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASIAN GINSENG (UNII: CUQ3A77YXI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
ISOSORBIDE DICAPRYLATE (UNII: 0IK29C4889)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
AMINOPROPYL ASCORBYL PHOSPHATE (UNII: 290O2PQ83R)
C12-16 ALCOHOLS (UNII: S4827SZE3L)
PALMITIC ACID (UNII: 2V16EO95H1)
TREHALOSE (UNII: B8WCK70T7I)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
SQUALANE (UNII: GW89575KF9)
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SHEA BUTTER (UNII: K49155WL9Y)
TRISILOXANE (UNII: 9G1ZW13R0G)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PROPANEDIOL (UNII: 5965N8W85T)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
PULLULAN (UNII: 8ZQ0AYU1TT)
MONTMORILLONITE (UNII: A585MN1H2L)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
CITRUS BIOFLAVONOIDS (UNII: BD70459I50)
BROCCOLI SPROUT (UNII: 128UH9LOAE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54473-277-01	1 in 1 BOX	01/01/2018
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/01/2017

Labeler - Melaleuca, Inc. (139760102)

Establishment
Name	Address	ID/FEI	Business Operations
Melaleuca, Inc.		079711683	manufacture(54473-277)