![FACIAL BOOSTING BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]](https://medic.hrt.org//dailymed/images/53761840-d8c9-4ca2-8dd3-2ceb638e3786/back.jpg)
![FACIAL BOOSTING BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]](https://medic.hrt.org//dailymed/images/53761840-d8c9-4ca2-8dd3-2ceb638e3786/front.jpg)
| NDC | 68828-159-01, 68828-159-02 |
| Set ID | 53761840-d8c9-4ca2-8dd3-2ceb638e3786 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | JAFRA COSMETICS INTERNATIONAL |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
-
ACTIVE INGREDIENT
Active Ingredients Purpose
Avobenzone 2.5% Sunscreen
Octinoxate 7.5 % Sunscreen
Octisalate 4 % Sunscreen
Oxybenzone 2% Sunscreen
Uses
helps prevents 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. If product is swallowed, get medical help or contact a Poison Control Center right away.
Stop use and ask a doctor if rash occurs.
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.
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: 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
Inactive Ingredients
Water/Aqua, Cetearyl Alcohol, Ceteareth-20, Glycerin, Stearyl Stearate, Myristyl Myristate, Sodium PCA, Pentylene Glycol, Garcinia Indica Seed Butter, Cyclomethicone, Dimethiconol, Bis-Diglyceryl Polyacyladipate-2, Cetyl Alcohol, Butyrospermum Parkii (Shea Butter) Fruit, Castanea Sativa (Chestnut) Seed Extract, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Ceramide 2, PEG 10 Brassica Campestris Sterol, Palmitoyl Oligopeptide, C12-15 Alkyl Benzoate, Tribehenin, Glycyrrhiza Glabra (Licorice) Extract, Moringa Oliefera Extract, Vetivera Zinzanoids (Khus Root) Extract, Withania Somnifera (Winter Cherry) Extract, Tocopherol, Fragrance/parfum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Panthenol, Biosaccharide Gum-4, Chondrus Crispus (Carrageenan) Extract, Glycine Soja (Soybean) Isoflavone Aglycone, Lecithin, Polysorbate 80, Mentha Piperita (peppermint) Extract, Alcohol, Trisodium EDTA, PEG-4 Laurate, Iodopropynyl Butylcarbamate. - PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FACIAL BOOSTING BROAD SPECTRUM SPF 15 JAFRA
avobenzone, octinoxate, octisalate, oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-159 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 25 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 40 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) GLYCERIN (UNII: PDC6A3C0OX) STEARYL STEARATE (UNII: 5WX2EGD0DK) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) PENTYLENE GLYCOL (UNII: 50C1307PZG) GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800) CYCLOMETHICONE (UNII: NMQ347994Z) DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y) CETYL ALCOHOL (UNII: 936JST6JCN) SHEA BUTTER (UNII: K49155WL9Y) SPANISH CHESTNUT (UNII: 2MT5XMR2YW) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HEXYLENE GLYCOL (UNII: KEH0A3F75J) CERAMIDE 2 (UNII: C04977SRJ5) PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) TRIBEHENIN (UNII: 8OC9U7TQZ0) LICORICE (UNII: 61ZBX54883) TOCOPHEROL (UNII: R0ZB2556P8) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) TROLAMINE (UNII: 9O3K93S3TK) PANTHENOL (UNII: WV9CM0O67Z) CHONDRUS CRISPUS (UNII: OQS23HUA1X) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYSORBATE 80 (UNII: 6OZP39ZG8H) MENTHA PIPERITA (UNII: 79M2M2UDA9) ALCOHOL (UNII: 3K9958V90M) EDETATE TRISODIUM (UNII: 420IP921MB) PEG-4 LAURATE (UNII: AYF4VM3N1Z) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-159-02 1 in 1 CARTON 11/30/2012 1 NDC:68828-159-01 50 mL in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/30/2012 Labeler - JAFRA COSMETICS INTERNATIONAL (041676479) Registrant - JAFRA COSMETICS INTERNATIONAL (041676479) Establishment Name Address ID/FEI Business Operations Jafra Manufacturing, S.A. de C.V. 814732061 manufacture(68828-159)
