![3-IN-1 FACE MOISTURIZER BROAD SPECTRUM SPF 20 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) JELLY [JAFRA COSMETICS INTERNATIONAL]](https://medic.hrt.org//dailymed/images/85169b9d-441c-eb4a-e053-2991aa0abd8e/Men3in1FaceMoistSPF20.jpg)
| NDC | 68828-283-01 |
| Set ID | 85169b9d-441c-eb4a-e053-2991aa0abd8e |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Jafra cosmetics International |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- WARNINGS
- INDICATIONS & USAGE
-
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
-
INGREDIENTS AND APPEARANCE
3-IN-1 FACE MOISTURIZER BROAD SPECTRUM SPF 20
avobenzone, homosalate, octisalate, octocrylene jellyProduct 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)
