3-IN-1 FACE MOISTURIZER BROAD SPECTRUM SPF 20- avobenzone, homosalate, octisalate, octocrylene jelly

3-in-1 Face Moisturizer Broad Spectrum SPF 20 by

Drug Labeling and Warnings

3-in-1 Face Moisturizer Broad Spectrum SPF 20 by is a Otc medication manufactured, distributed, or labeled by Jafra cosmetics International, Jafra Manufacturing, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Purpose

Avobenzone 3% Sunscreen

Homosalate 10% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 10% Sunscreen

PURPOSE

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

If product is swallowed, get medical help or contact a poison Control Center right away

WARNINGS

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

INDICATIONS & USAGE

Stop use and ask a doctor if

rash occurs or irritation develops and lasts.

DOSAGE & ADMINISTRATION

Directions

• Apply liberally 15 minutes before sun exposure
• Use a water resistant sunscreen if swimming or sweating
• reapply at leastevery 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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

Jafra Royal Men

Royal Jelly

3-in-1 Face Moisturizer Broad Spectrum SPF 20

75 ml 2.5 Fl Oz

INGREDIENTS AND APPEARANCE

3-IN-1 FACE MOISTURIZER BROAD SPECTRUM SPF 20 
avobenzone, homosalate, octisalate, octocrylene jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-283
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 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

Inactive Ingredients
Ingredient Name	Strength
ROYAL JELLY (UNII: L497I37F0C)
SALIX ALBA BARK (UNII: 205MXS71H7)
UREA (UNII: 8W8T17847W)
DOCOSANOL (UNII: 9G1OE216XY)
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SHEA BUTTER (UNII: K49155WL9Y)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIACETIN (UNII: XHX3C3X673)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
ALLANTOIN, (+)- (UNII: XDK458E1J9)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
C13-16 ISOPARAFFIN (UNII: LED42LZG6O)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
LAUROYL LYSINE (UNII: 113171Q70B)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
CAFFEINE (UNII: 3G6A5W338E)
CITRAL (UNII: T7EU0O9VPP)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
COCOA (UNII: D9108TZ9KG)
TOCOPHEROL (UNII: R0ZB2556P8)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)
PEG-100 STEARATE (UNII: YD01N1999R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
COUMARIN (UNII: A4VZ22K1WT)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
ARGININE (UNII: 94ZLA3W45F)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TREHALOSE (UNII: B8WCK70T7I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-283-01	75 mL in 1 CARTON; Type 0: Not a Combination Product	03/27/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/27/2019

Labeler - Jafra cosmetics International (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Jafra Manufacturing, S.A. de C.V.		814732061	manufacture(68828-283)