Label: LIGHT SKIN DEFENSE CONCEALER BROAD SPECTRUM SPF 15 JAFRA- octinoxate, octisalate, oxybenzone cream
MEDIUM SKIN DEFENSE CONCEALER BROAD SPECTRUM SPF 15 JAFRA- octinoxate, octisalate, oxybenzone cream
DARK SKIN DEFENSE CONCEALER BROAD SPECTRUM SPF 15 JAFRA- octinoxate, octisalate, oxybenzone cream
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NDC Code(s):
68828-170-01,
68828-170-02,
68828-171-01,
68828-171-02, view more68828-172-01, 68828-172-02
- Packager: Jafra Cosmetics International Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 5, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active Ingredients Purpose
Octinoxate 7% Sunscreen
Octisalate 3% Sunscreen
Oxybenzone 2% 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
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 doctorif rash occurs
Warnings
For external use only
Do not use on damaged or broken skin
When using this productkeep out of eyes. Rinse with water to remove.
Directions
Apply liberally 15 minutes before sun exposure
Reapply at least every 2 hours
Use a water resistant sunscreen if swimming or sweating
Children under 6 months: Ask a doctorSun 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 broad spectrum SPF of 15 or higher and other sun protection measures
including:
limit time in the sun, especially from 10 a.m. - 2 p.m.
wear long-sleeve shirts, pants, hats, and sunglassesInactive ingredients: Water/Aqua, Butylene Glycol, Glyceryl Stearate, Stearic Acid, Isopropyl Isostearate, Di-PPG-3 Myristyl Ether Adipate, Potassium Cetyl Phosphate, Hydrogenated Palm Glycerides, Cetyl Alcohol, Triethanolamine, Lecithin, Silica, Dimethicone, Polysorbate 20, Hydrolyzed Lupinus Albus (Lupine) Protein, Medicago Sativa (Alfalfa) Seed Extract, DMDM Hydantoin, Xanthan Gum, Biosaccharide Gum-4, Chondrus Crispus (Carrageenan) Extract, Magnesium Aluminum Silicate, Tocopheryl Acetate, Tagetus Erecta (African Marigold) Extract, Ipomoea Batatas Tuber Extract, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Trisodium EDTA [May Contain +/- : Titanium Dioxide/CI 77891, Iron Oxides/CI 77491/CI 77492/CI 77499]
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LIGHT SKIN DEFENSE CONCEALER BROAD SPECTRUM SPF 15 JAFRA
octinoxate, octisalate, oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-170 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 3 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 2 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) STEARIC ACID (UNII: 4ELV7Z65AP) ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T) DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q) CETYL ALCOHOL (UNII: 936JST6JCN) TROLAMINE (UNII: 9O3K93S3TK) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIMETHICONE (UNII: 92RU3N3Y1O) POLYSORBATE 20 (UNII: 7T1F30V5YH) ALFALFA SEED (UNII: 67PHZ58858) DMDM HYDANTOIN (UNII: BYR0546TOW) XANTHAN GUM (UNII: TTV12P4NEE) CHONDRUS CRISPUS (UNII: OQS23HUA1X) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SWEET POTATO (UNII: M9WGG9Z9GK) PEG-4 LAURATE (UNII: AYF4VM3N1Z) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) EDETATE TRISODIUM (UNII: 420IP921MB) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-170-02 1 in 1 CARTON 05/22/2013 12/31/2023 1 NDC:68828-170-01 15 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 05/22/2013 12/31/2023 MEDIUM SKIN DEFENSE CONCEALER BROAD SPECTRUM SPF 15 JAFRA
octinoxate, octisalate, oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-171 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 3 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 2 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) STEARIC ACID (UNII: 4ELV7Z65AP) ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T) DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q) CETYL ALCOHOL (UNII: 936JST6JCN) TROLAMINE (UNII: 9O3K93S3TK) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIMETHICONE (UNII: 92RU3N3Y1O) POLYSORBATE 20 (UNII: 7T1F30V5YH) ALFALFA SEED (UNII: 67PHZ58858) DMDM HYDANTOIN (UNII: BYR0546TOW) XANTHAN GUM (UNII: TTV12P4NEE) CHONDRUS CRISPUS (UNII: OQS23HUA1X) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SWEET POTATO (UNII: M9WGG9Z9GK) PEG-4 LAURATE (UNII: AYF4VM3N1Z) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) EDETATE TRISODIUM (UNII: 420IP921MB) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-171-02 1 in 1 CARTON 05/22/2013 12/31/2023 1 NDC:68828-171-01 15 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 05/22/2013 12/31/2023 DARK SKIN DEFENSE CONCEALER BROAD SPECTRUM SPF 15 JAFRA
octinoxate, octisalate, oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-172 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 3 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 2 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) STEARIC ACID (UNII: 4ELV7Z65AP) ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T) DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q) CETYL ALCOHOL (UNII: 936JST6JCN) TROLAMINE (UNII: 9O3K93S3TK) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIMETHICONE (UNII: 92RU3N3Y1O) POLYSORBATE 20 (UNII: 7T1F30V5YH) ALFALFA SEED (UNII: 67PHZ58858) DMDM HYDANTOIN (UNII: BYR0546TOW) XANTHAN GUM (UNII: TTV12P4NEE) CHONDRUS CRISPUS (UNII: OQS23HUA1X) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SWEET POTATO (UNII: M9WGG9Z9GK) PEG-4 LAURATE (UNII: AYF4VM3N1Z) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) EDETATE TRISODIUM (UNII: 420IP921MB) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-172-02 1 in 1 CARTON 05/22/2013 06/01/2019 1 NDC:68828-172-01 15 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 05/22/2013 Labeler - Jafra Cosmetics International Inc (041676479) Registrant - Jafra Cosmetics International Inc (041676479) Establishment Name Address ID/FEI Business Operations Distribuidora Comercial Jafra, S.A. de C.V. 951612777 manufacture(68828-170, 68828-171, 68828-172)
