Active Ingredient(s)

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 10%

Purpose

Sunscreen

Uses

Helps prevent sunburn
If 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 useon damaged or broken skin

Whe using this productkeep out of eyes. Rinse with water to remove.

Stop use and ask a doctorif rash occurs

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• children under 6 months of age: Ask a doctor
• 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 your time in the sun, especially from 10 a.m. – 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients

Water, Glycerin, Dimethicone, Styrene/Acrylates Copolymer, Silica, Aluminum Starch Octenylsuccinate, Butyloctyl Salicylate, Heptyl Undecylenate, Polyester-8, Phenoxyethanol, Glyceryl Stearate, PEG-100 Stearate, C13-16 Isoparaffin, Lauroyl Lysine, Arachidyl Alcohol, Behenyl Alcohol, Arachidyl Glucoside, Royal Jelly Powder, Tetrapeptide-45, Hydrogenated Lecithin, Butyrospermum Parkii (Shea) Butter, Royal Jelly, Salix Alba (Willow) Bark Extract, Quercus Petraea Fruit Extract, Cetyl Alcohol, Ethylhexyl Methoxycrylene, Capryloyl Glycerin/Sebacic Acid Copolymer, Xanthan Gum, Sodium Hyaluronate, Trehalose, Sodium PCA, Polyquaternium-51, Urea, Triacetin, Caffeine, Allantoin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Acrylates Crosspolymer-2, Arginine, Ethylhexylglycerin, Tocopherol, Fragrance, Citronellol, Coumarin, Limonene, Linalool, Disodium EDTA, Butylene Glycol, Theobroma Cacao (Cocoa) Seed Extract, Yeast Extract, Bisabolol, Phenethyl Alcohol, Maltodextrin, Lecithin, Dipropylene Glycol

Other information

Protect this product from excessive heat and direct sun

Product label

image description

ROYAL MEN SAMPLE SET
avobenzone, homosalate, octisalate, octocrylene kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68828-765

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68828-765-01	1 in 1 KIT; Type 1: Convenience Kit of Co-Package	03/09/2022	06/30/2024

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 TUBE	7.5 mL in 100
Part 2	1 TUBE	7.5 mL in 100
Part 3	1 TUBE	25 mL in 100
Part 4	1 TUBE	7.5 mL in 100

Part 1 of 4

ROYAL MEN 3-IN-1 FACE MOISTURIZER BROAD SPECTRUM SPF 20
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Item Code (Source)	NDC:68828-766
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
C13-16 ISOPARAFFIN (UNII: LED42LZG6O)
LAUROYL LYSINE (UNII: 113171Q70B)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
DOCOSANOL (UNII: 9G1OE216XY)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
SHEA BUTTER (UNII: K49155WL9Y)
ROYAL JELLY (UNII: L497I37F0C)
SALIX ALBA BARK (UNII: 205MXS71H7)
QUERCUS PETRAEA WHOLE (UNII: 45C533V2SL)
CETYL ALCOHOL (UNII: 936JST6JCN)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
XANTHAN GUM (UNII: TTV12P4NEE)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TREHALOSE (UNII: B8WCK70T7I)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
UREA (UNII: 8W8T17847W)
TRIACETIN (UNII: XHX3C3X673)
CAFFEINE (UNII: 3G6A5W338E)
ALLANTOIN (UNII: 344S277G0Z)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
ARGININE (UNII: 94ZLA3W45F)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TOCOPHEROL (UNII: R0ZB2556P8)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
COUMARIN (UNII: A4VZ22K1WT)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
COCOA (UNII: D9108TZ9KG)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
LEVOMENOL (UNII: 24WE03BX2T)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
DIPROPYLENE GLYCOL (UNII: E107L85C40)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68828-766-01	7.5 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	01/13/2022	06/30/2024

Part 2 of 4

CLEAN AND CONDITION FACE WASH
other skin care preparations, leave-on [skin care preparations (creams, lotions, powder, and sprays)] gel

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	WATER (UNII: 059QF0KO0R)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	SODIUM LAUROYL METHYL ISETHIONATE (UNII: II6VCD3S6R)
INGR	SODIUM METHYL OLEOYL TAURATE (UNII: 8PZ076134H)
INGR	LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
INGR	COCO GLUCOSIDE (UNII: ICS790225B)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	CAFFEINE (UNII: 3G6A5W338E)
INGR	ROYAL JELLY (UNII: L497I37F0C)
INGR	HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
INGR	MALTODEXTRIN (UNII: 7CVR7L4A2D)
INGR	LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
INGR	DIPROPYLENE GLYCOL (UNII: E107L85C40)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	BENZOIC ACID (UNII: 8SKN0B0MIM)
INGR	DEHYDROACETIC ACID (UNII: 2KAG279R6R)
INGR	.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
INGR	COUMARIN (UNII: A4VZ22K1WT)
INGR	LIMONENE, (+)- (UNII: GFD7C86Q1W)
INGR	LINALOOL, (+/-)- (UNII: D81QY6I88E)
INGR	TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
INGR	SODIUM CHLORIDE (UNII: 451W47IQ8X)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	SALIX ALBA BARK (UNII: 205MXS71H7)
INGR	QUERCUS PETRAEA WHOLE (UNII: 45C533V2SL)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		7.5 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		01/14/2022

Part 3 of 4

POST SHAVE FACE TONIC
other skin care preparations, leave-on [skin care preparations (creams, lotions, powder, and sprays)] liquid

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	WATER (UNII: 059QF0KO0R)
INGR	ALCOHOL (UNII: 3K9958V90M)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	HAMAMELIS VIRGINIANA WHOLE (UNII: V663Q8TEFU)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	TREHALOSE (UNII: B8WCK70T7I)
INGR	SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
INGR	POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
INGR	UREA (UNII: 8W8T17847W)
INGR	TRIACETIN (UNII: XHX3C3X673)
INGR	SALICYLIC ACID (UNII: O414PZ4LPZ)
INGR	ROYAL JELLY (UNII: L497I37F0C)
INGR	LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
INGR	DIPROPYLENE GLYCOL (UNII: E107L85C40)
INGR	HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
INGR	TROLAMINE (UNII: 9O3K93S3TK)
INGR	CAFFEINE (UNII: 3G6A5W338E)
INGR	POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
INGR	PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
INGR	POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
INGR	EDETATE DISODIUM (UNII: 7FLD91C86K)
INGR	SALIX ALBA BARK (UNII: 205MXS71H7)
INGR	QUERCUS PETRAEA WHOLE (UNII: 45C533V2SL)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	MALTODEXTRIN (UNII: 7CVR7L4A2D)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	LEVOMENOL (UNII: 24WE03BX2T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		25 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		01/14/2022

Part 4 of 4

AGE DEFENSE FACE HYDRATOR
other skin care preparations, leave-on [skin care preparations (creams, lotions, powder, and sprays)] cream

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	WATER (UNII: 059QF0KO0R)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
INGR	STEARYL STEARATE (UNII: 5WX2EGD0DK)
INGR	CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
INGR	HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
INGR	C13-16 ISOPARAFFIN (UNII: LED42LZG6O)
INGR	ROYAL JELLY (UNII: L497I37F0C)
INGR	LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
INGR	DIPROPYLENE GLYCOL (UNII: E107L85C40)
INGR	HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	HEXYLENE GLYCOL (UNII: KEH0A3F75J)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	ROSA CANINA FRUIT (UNII: 3TNW8D08V3)
INGR	PALMARIA PALMATA (UNII: 7832HOY4ZQ)
INGR	TROLAMINE (UNII: 9O3K93S3TK)
INGR	MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
INGR	SODIUM ACRYLATES CROSSPOLYMER-2 (UNII: D3HPR4WW6F)
INGR	BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
INGR	SALIX ALBA BARK (UNII: 205MXS71H7)
INGR	LEVOMENOL (UNII: 24WE03BX2T)
INGR	CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)
INGR	CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	CAFFEINE (UNII: 3G6A5W338E)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
INGR	COUMARIN (UNII: A4VZ22K1WT)
INGR	LIMONENE, (+)- (UNII: GFD7C86Q1W)
INGR	LINALOOL, (+/-)- (UNII: D81QY6I88E)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
INGR	MALTODEXTRIN (UNII: 7CVR7L4A2D)
INGR	QUERCUS PETRAEA WHOLE (UNII: 45C533V2SL)
INGR	EDETATE TRISODIUM (UNII: 420IP921MB)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		7.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		01/14/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	03/09/2022	06/30/2024