BROTEGE GOOD BOY PROTECTION SPF 15 AND RETINOL DAILY MOISTURIZER- benzophenone-3, butyle methoxydibenzoylmethane, ethylhexyl salicylate, octocrylene cream

BROTEGE Good Boy Protection SPF 15 and Retinol Daily Moisturizer by

Drug Labeling and Warnings

BROTEGE Good Boy Protection SPF 15 and Retinol Daily Moisturizer by is a Otc medication manufactured, distributed, or labeled by Spa de Soleil. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Benzophenone-3 4%

Butyl Methoxydibenzoylmethane 1.5%

Ethylhexyl Salicylate 5.0%

Octocrylene 2.5%

Purpose

Sunscreen

Warnings

Warnings

Do not use on damaged or broken skin

When using this product

• keep out of the eye area
• rinse with water to remove
• stop use and ask a doctor if rash or irritation develops
• for external use onlyl
• keep out of reach of children

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Directions

Directions: for sunscreen use

apply generously 15 minutes before sun exposure

apply to all skin exposed to the sun

children under 6 months of age: ask a doctor

INDICATIONS & USAGE

Apply generously and evenly thirty minutes before sun exposure. Reapply at least every two hours.

Inactive Ingredients

Inactive Ingredients: Aqua, Glycerin, C12-15 Alkyl Benzoate, Cetyl Alcohol, Silica, Butylene Glycol, Cyclopentasiloxane, Sucrose Polystearate, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Glucoside, Cetearyl Alcohol, Carbomer, Cetyl Palmitate, Disodium EDTA, Tocopheryl Acetate (Vitamin E), Sodium Hydroxide, Panthenol, Retinol, Polysorbate 20, Camellia Oleifera Seed Extract, BHT, Phenoxyethanol, Ethylhexylglycerin

Principal Display Panel

INGREDIENTS AND APPEARANCE

BROTEGE GOOD BOY PROTECTION SPF 15 AND RETINOL DAILY MOISTURIZER 
benzophenone-3, butyle methoxydibenzoylmethane, ethylhexyl salicylate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68062-9981
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 40 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.6 g  in 40 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.6 g  in 40 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2 g  in 40 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 940 (UNII: 4Q93RCW27E)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
C12-15 ALKYL ETHYLHEXANOATE (UNII: GQJ580CH83)
CETYL ALCOHOL (UNII: 936JST6JCN)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE (UNII: NMQ347994Z)
SUCROSE POLYSTEARATE (UNII: SZF3GPA9YV)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PEG-100 STEARATE (UNII: YD01N1999R)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ASCORBYL TOCOPHERYL MALEATE (UNII: D2G6259XR5)
PANTHENOL (UNII: WV9CM0O67Z)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CAMELLIA OLEIFERA SEED (UNII: 59ED29FM2J)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
RETINOL (UNII: G2SH0XKK91)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68062-9981-1	40 mL in 1 TUBE; Type 0: Not a Combination Product	08/09/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/09/2024

Labeler - Spa de Soleil (874682867)

Establishment
Name	Address	ID/FEI	Business Operations
Spa de Soleil		874682867	manufacture(68062-9981)