REVERSE BRIGHTENING DEFENSE FLUID- avobenzone, homosalate, octocrylene, octisalate lotion

REVERSE Brightening Defense Fluid by

Drug Labeling and Warnings

REVERSE Brightening Defense Fluid by is a Otc medication manufactured, distributed, or labeled by Rodan & Fields. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Avobenzone 2.8%,

Homosalate 9.3%,

Octisalate 4.67%,

Octocrylene 6.1%

Purpose

Sunscreen

Uses

• Helps prevent sunburn.
• When used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only.

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

Directions

• Every AM, apply liberally and evenly over face + neck 15 minutes before sun exposure.
• Reapply at least every 2 hours.
• Use a water-resistant sunscreen if swimming or sweating.
• Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun

protection measures including:

• Limit time in the sun, especially from 10 a.m-2 p.m.
• Wear long-sleeve shirts, pants, hats and sunglasses.
• Children under 6 months: Ask a doctor.

Inactive Ingredients

Adenosine, Aminomethyl Propanol, Aqua/Eau/Water, Benzyl Alcohol, Butylene Glycol, C12-15 Alkyl Benzoate, Calcium Gluconate, Citral, Citric Acid, Cynara Scolymus (Artichoke) Leaf Extract, Dimethicone, Dimethicone/Vinyl Dime­thicone Crosspolymer, Dipotassium Glycyrrhizate, Fragrance/Parfum, Glucono­lactone, Glycerin, Glycine Soja (Soybean) Oil, Hydrogenated Lecithin, Limonene, Linalool, Methyl Carboxymethylphenyl Aminocarboxypropylphosphonate, Phenoxyethanol, Propanediol, Rosmarinic Acid, Rutin, Sesamum Indicum (Sesame) Seed Extract, Silica, Sodium Benzoate, Sodium Carbomer, Titanium Dioxide (Cl 77891), Tocopherol, Xanthan Gum.

Other Information

Protect this product from excessive heat and direct sun.

Questions?

1-888-995-5656

Principal Display Panel - 30 mL Carton Label

RODAN+FIELDS

REVERSE

Brightening Defense
Fluid Lotion

Broad Spectrum SPF 50

3AM

30 mL/1. Fl. Oz. U.S.

Principal Display Panel - 30 mL Tube Label

RODAN+FIELDS

REVERSE

Brightening Defense Fluid Lotion

Broad Spectrum SPF 50

3AM

INGREDIENTS AND APPEARANCE

REVERSE BRIGHTENING DEFENSE FLUID 
avobenzone, homosalate, octocrylene, octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14222-2300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.028 g  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.093 g  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.061 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.0467 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ADENOSINE (UNII: K72T3FS567)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CALCIUM GLUCONATE (UNII: SQE6VB453K)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CITRAL (UNII: T7EU0O9VPP)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CYNARA SCOLYMUS LEAF (UNII: B71UA545DE)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPANEDIOL (UNII: 5965N8W85T)
ROSMARINIC ACID (UNII: MQE6XG29YI)
RUTIN (UNII: 5G06TVY3R7)
SESAME SEED (UNII: 7Y1255HVXR)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SOYBEAN OIL (UNII: 241ATL177A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14222-2300-1	1 in 1 CARTON	03/09/2021
1		30 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 14222-2300-2	1 in 1 CARTON	06/01/2021
2		7 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 14222-2300-3	2 mL in 1 PACKET; Type 0: Not a Combination Product	04/12/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/09/2021

Labeler - Rodan & Fields (051659584)