REVITALIZE SOLAR PROTECTION FLUID BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene cream

Jafra Royal Defy Travel Kit by

Drug Labeling and Warnings

Jafra Royal Defy Travel Kit by is a Otc medication manufactured, distributed, or labeled by Jafra cosmetics International, Distribuidora Comercial Jafra, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 7%

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 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

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

Directions

• apply liberally and evenly 15 minutes before sun exposure
• reapply at least every 2 hours.
• use a water-resistant sunscreen if swimming or sweating
• 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

Other information

• protect this product from excessive heat and direct sun

Inactive ingredients

Water, Styrene/Acrylates Copolymer, Aluminum Starch Octenylsuccinate, Ethylhexylglycerin, Benzyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Arachidyl Alcohol, Bisabolol, Behenyl Alcohol, Cyclopentasiloxane, Lauroyl Lysine, Fragrance, Arachidyl Glucoside, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Allantoin, Arginine, Chlorphenesin, Acrylates/Dimethicone Copolymer, Royal Jelly Powder, Glycerin, Benzyl Salicylate, Butyrospermum Parkii (Shea) Butter, Dipropylene Glycol, Sodium Ascorbyl Phosphate, Lecithin, Hydroxycitronellal, Limonene, Hydrogenated Lecithin, Linalool, Royal Jelly, Polygonum Aviculare Extract, Phenethyl Alcohol, Cocos Nucifera (Coconut) Fruit Extract, Butylene Glycol, Actinidia Chinensis (Kiwi) Fruit Water, Moringa Oleifera Leaf Extract, Maltodextrin, Tetrapeptide-45, Alcohol, Sophora Flavescens Root Extract

Questions?

Call 1-800-551-2345 or visit www.jafra.com

Product label

INGREDIENTS AND APPEARANCE

REVITALIZE SOLAR PROTECTION FLUID BROAD SPECTRUM SPF 50 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-515
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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	7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
KIWI FRUIT OIL (UNII: 66086CWP3Q)
ALCOHOL (UNII: 3K9958V90M)
ALLANTOIN (UNII: 344S277G0Z)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
ARGININE (UNII: 94ZLA3W45F)
DOCOSANOL (UNII: 9G1OE216XY)
BENZYL ALCOHOL (UNII: LKG8494WBH)
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SHEA BUTTER (UNII: K49155WL9Y)
CHLORPHENESIN (UNII: I670DAL4SZ)
COCONUT (UNII: 3RT3536DHY)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
LAUROYL LYSINE (UNII: 113171Q70B)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MORINGA OLEIFERA LEAF (UNII: 4WET1AWO9B)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)
ROYAL JELLY (UNII: L497I37F0C)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
WATER (UNII: 059QF0KO0R)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-515-01	1 in 1 CARTON	08/22/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/22/2022

Labeler - Distribuidora Comercial Jafra, S.A. de C.V. (951612777)

Registrant - Jafra Cosmetics International, Inc. (031183599)

Establishment
Name	Address	ID/FEI	Business Operations
Distribuidora Comercial Jafra, S.A. de C.V.		951612777	manufacture(68828-515)