Label: PROTECTINT 20C- homosalate, octisalate, zinc oxide cream
PROTECTINT 26W- homosalate, octisalate, zinc oxide cream
PROTECTINT 32N- homosalate, octisalate, zinc oxide cream
PROTECTINT 34C- homosalate, octisalate, zinc oxide cream
PROTECTINT 58W- homosalate, octisalate, zinc oxide cream
PROTECTINT 10N- homosalate, octisalate, zinc oxide cream
PROTECTINT 24N- homosalate, octisalate, zinc oxide cream
PROTECTINT 22W- homosalate, octisalate, zinc oxide cream
PROTECTINT 30W- homosalate, octisalate, zinc oxide cream
PROTECTINT 46N- homosalate, octisalate, zinc oxide cream
PROTECTINT 42C- homosalate, octisalate, zinc oxide cream
PROTECTINT 52N- homosalate, octisalate, zinc oxide cream
PROTECTINT 14N- homosalate, octisalate, zinc oxide cream
PROTECTINT 40W- homosalate, octisalate, zinc oxide cream
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NDC Code(s):
59735-906-01,
59735-906-02,
59735-907-01,
59735-907-02, view more59735-908-01, 59735-908-02, 59735-909-01, 59735-909-02, 59735-910-01, 59735-910-02, 59735-911-01, 59735-911-02, 59735-912-01, 59735-912-02, 59735-913-01, 59735-913-02, 59735-914-01, 59735-914-02, 59735-915-01, 59735-915-02, 59735-916-01, 59735-916-02, 59735-917-01, 59735-917-02, 59735-918-01, 59735-918-02, 59735-919-01, 59735-919-02
- Packager: MANA PRODUCTS, INC.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated June 26, 2024
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- WARNINGS
- INDICATIONS & USAGE
-
DOSAGE & ADMINISTRATION
Directions
Apply generously and evenly 15 minutes before sun exposure
Reapply at least every 2 hours
Use a water resistant sunscreen if swimming or sweating
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 time in the sun, especially from 10 a.m.- 2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses
- Children under 6 months: Ask a doctor
-
INACTIVE INGREDIENT
Inactive Ingredients:IAqua/Water/Eau, Isononyl Isononanoate, Butyloctyl Salicylate, Propanediol, Silica, Glycerin,1,2-Hexanediol, Lecithin, Coco-Caprylate/Caprate, Cetearyl Alcohol, Lauryl Glucoside, Polyglyceryl-2 Dipolyhydroxystearate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Ectoin, Coco-Glucoside, Polyhydroxystearic acid, Citric Acid, Triethoxycaprylylsilane, Morinda Citrifolia Extract, Xanthan Gum, Sodium Phytate, Bentonite, Sodium Hyaluronate, Tocopherol
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PROTECTINT 20C
homosalate, octisalate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59735-906 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 13.58 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength XANTHAN GUM (UNII: TTV12P4NEE) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PROPANEDIOL (UNII: 5965N8W85T) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) COCO GLUCOSIDE (UNII: ICS790225B) WATER (UNII: 059QF0KO0R) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BENTONITE (UNII: A3N5ZCN45C) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ECTOINE (UNII: 7GXZ3858RY) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) TOCOPHEROL (UNII: R0ZB2556P8) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) GLYCERIN (UNII: PDC6A3C0OX) NONI FRUIT (UNII: 7829X3G2X5) PHYTATE SODIUM (UNII: 88496G1ERL) FERROSOFERRIC OXIDE (UNII: XM0M87F357) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) Product Characteristics Color white (20C) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59735-906-02 1 in 1 BOX 11/22/2023 1 NDC:59735-906-01 35 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 11/22/2023 PROTECTINT 26W
homosalate, octisalate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59735-907 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 13.58 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength TOCOPHEROL (UNII: R0ZB2556P8) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) GLYCERIN (UNII: PDC6A3C0OX) NONI FRUIT (UNII: 7829X3G2X5) PHYTATE SODIUM (UNII: 88496G1ERL) FERROSOFERRIC OXIDE (UNII: XM0M87F357) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) XANTHAN GUM (UNII: TTV12P4NEE) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PROPANEDIOL (UNII: 5965N8W85T) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) COCO GLUCOSIDE (UNII: ICS790225B) WATER (UNII: 059QF0KO0R) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BENTONITE (UNII: A3N5ZCN45C) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ECTOINE (UNII: 7GXZ3858RY) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Product Characteristics Color white (26W) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59735-907-02 1 in 1 BOX 11/22/2023 1 NDC:59735-907-01 35 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 11/22/2023 PROTECTINT 32N
homosalate, octisalate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59735-908 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 13.58 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength TOCOPHEROL (UNII: R0ZB2556P8) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) GLYCERIN (UNII: PDC6A3C0OX) NONI FRUIT (UNII: 7829X3G2X5) PHYTATE SODIUM (UNII: 88496G1ERL) FERROSOFERRIC OXIDE (UNII: XM0M87F357) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) XANTHAN GUM (UNII: TTV12P4NEE) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PROPANEDIOL (UNII: 5965N8W85T) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) COCO GLUCOSIDE (UNII: ICS790225B) WATER (UNII: 059QF0KO0R) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BENTONITE (UNII: A3N5ZCN45C) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ECTOINE (UNII: 7GXZ3858RY) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Product Characteristics Color brown (32N) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59735-908-02 1 in 1 BOX 11/22/2023 1 NDC:59735-908-01 35 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 11/22/2023 PROTECTINT 34C
homosalate, octisalate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59735-909 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 13.58 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength TOCOPHEROL (UNII: R0ZB2556P8) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) GLYCERIN (UNII: PDC6A3C0OX) NONI FRUIT (UNII: 7829X3G2X5) PHYTATE SODIUM (UNII: 88496G1ERL) FERROSOFERRIC OXIDE (UNII: XM0M87F357) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) XANTHAN GUM (UNII: TTV12P4NEE) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PROPANEDIOL (UNII: 5965N8W85T) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) COCO GLUCOSIDE (UNII: ICS790225B) WATER (UNII: 059QF0KO0R) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BENTONITE (UNII: A3N5ZCN45C) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ECTOINE (UNII: 7GXZ3858RY) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Product Characteristics Color brown (34C) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59735-909-02 1 in 1 BOX 11/22/2023 1 NDC:59735-909-01 35 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 11/22/2023 PROTECTINT 58W
homosalate, octisalate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59735-910 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 13.58 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength TOCOPHEROL (UNII: R0ZB2556P8) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) GLYCERIN (UNII: PDC6A3C0OX) NONI FRUIT (UNII: 7829X3G2X5) PHYTATE SODIUM (UNII: 88496G1ERL) FERROSOFERRIC OXIDE (UNII: XM0M87F357) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) XANTHAN GUM (UNII: TTV12P4NEE) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PROPANEDIOL (UNII: 5965N8W85T) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) COCO GLUCOSIDE (UNII: ICS790225B) WATER (UNII: 059QF0KO0R) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BENTONITE (UNII: A3N5ZCN45C) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ECTOINE (UNII: 7GXZ3858RY) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Product Characteristics Color brown (58W) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59735-910-02 1 in 1 BOX 11/22/2023 1 NDC:59735-910-01 35 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 11/22/2023 PROTECTINT 10N
homosalate, octisalate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59735-911 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 13.58 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength TOCOPHEROL (UNII: R0ZB2556P8) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) PHYTATE SODIUM (UNII: 88496G1ERL) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) GLYCERIN (UNII: PDC6A3C0OX) NONI FRUIT (UNII: 7829X3G2X5) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) XANTHAN GUM (UNII: TTV12P4NEE) HYALURONATE SODIUM (UNII: YSE9PPT4TH) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) PROPANEDIOL (UNII: 5965N8W85T) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) COCO GLUCOSIDE (UNII: ICS790225B) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) WATER (UNII: 059QF0KO0R) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BENTONITE (UNII: A3N5ZCN45C) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ECTOINE (UNII: 7GXZ3858RY) Product Characteristics Color white (10N) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59735-911-02 1 in 1 BOX 11/22/2023 1 NDC:59735-911-01 35 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 11/22/2023 PROTECTINT 24N
homosalate, octisalate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59735-912 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 13.58 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength TOCOPHEROL (UNII: R0ZB2556P8) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) GLYCERIN (UNII: PDC6A3C0OX) NONI FRUIT (UNII: 7829X3G2X5) PHYTATE SODIUM (UNII: 88496G1ERL) FERROSOFERRIC OXIDE (UNII: XM0M87F357) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) XANTHAN GUM (UNII: TTV12P4NEE) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PROPANEDIOL (UNII: 5965N8W85T) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) COCO GLUCOSIDE (UNII: ICS790225B) WATER (UNII: 059QF0KO0R) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BENTONITE (UNII: A3N5ZCN45C) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ECTOINE (UNII: 7GXZ3858RY) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Product Characteristics Color white (24N) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59735-912-02 1 in 1 BOX 11/22/2023 1 NDC:59735-912-01 35 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 11/22/2023 PROTECTINT 22W
homosalate, octisalate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59735-913 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 13.58 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength TOCOPHEROL (UNII: R0ZB2556P8) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) GLYCERIN (UNII: PDC6A3C0OX) NONI FRUIT (UNII: 7829X3G2X5) PHYTATE SODIUM (UNII: 88496G1ERL) FERROSOFERRIC OXIDE (UNII: XM0M87F357) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) XANTHAN GUM (UNII: TTV12P4NEE) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PROPANEDIOL (UNII: 5965N8W85T) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) COCO GLUCOSIDE (UNII: ICS790225B) WATER (UNII: 059QF0KO0R) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BENTONITE (UNII: A3N5ZCN45C) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ECTOINE (UNII: 7GXZ3858RY) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Product Characteristics Color white (22W) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59735-913-02 1 in 1 BOX 11/22/2023 1 NDC:59735-913-01 35 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 11/22/2023 PROTECTINT 30W
homosalate, octisalate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59735-914 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 13.58 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength TOCOPHEROL (UNII: R0ZB2556P8) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) GLYCERIN (UNII: PDC6A3C0OX) NONI FRUIT (UNII: 7829X3G2X5) PHYTATE SODIUM (UNII: 88496G1ERL) FERROSOFERRIC OXIDE (UNII: XM0M87F357) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) XANTHAN GUM (UNII: TTV12P4NEE) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PROPANEDIOL (UNII: 5965N8W85T) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) COCO GLUCOSIDE (UNII: ICS790225B) WATER (UNII: 059QF0KO0R) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BENTONITE (UNII: A3N5ZCN45C) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ECTOINE (UNII: 7GXZ3858RY) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Product Characteristics Color brown (30W) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59735-914-02 1 in 1 BOX 11/22/2023 1 NDC:59735-914-01 35 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 11/22/2023 PROTECTINT 46N
homosalate, octisalate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59735-915 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 13.58 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength TOCOPHEROL (UNII: R0ZB2556P8) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) GLYCERIN (UNII: PDC6A3C0OX) NONI FRUIT (UNII: 7829X3G2X5) PHYTATE SODIUM (UNII: 88496G1ERL) FERROSOFERRIC OXIDE (UNII: XM0M87F357) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) XANTHAN GUM (UNII: TTV12P4NEE) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PROPANEDIOL (UNII: 5965N8W85T) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) COCO GLUCOSIDE (UNII: ICS790225B) WATER (UNII: 059QF0KO0R) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BENTONITE (UNII: A3N5ZCN45C) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ECTOINE (UNII: 7GXZ3858RY) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Product Characteristics Color brown (46N) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59735-915-02 1 in 1 BOX 11/22/2023 1 NDC:59735-915-01 35 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 11/22/2023 PROTECTINT 42C
homosalate, octisalate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59735-916 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 13.58 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength TOCOPHEROL (UNII: R0ZB2556P8) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) GLYCERIN (UNII: PDC6A3C0OX) NONI FRUIT (UNII: 7829X3G2X5) PHYTATE SODIUM (UNII: 88496G1ERL) FERROSOFERRIC OXIDE (UNII: XM0M87F357) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) XANTHAN GUM (UNII: TTV12P4NEE) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PROPANEDIOL (UNII: 5965N8W85T) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) COCO GLUCOSIDE (UNII: ICS790225B) WATER (UNII: 059QF0KO0R) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BENTONITE (UNII: A3N5ZCN45C) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ECTOINE (UNII: 7GXZ3858RY) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Product Characteristics Color brown (42C) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59735-916-02 1 in 1 BOX 11/22/2023 1 NDC:59735-916-01 35 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 11/22/2023 PROTECTINT 52N
homosalate, octisalate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59735-917 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 13.58 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength TOCOPHEROL (UNII: R0ZB2556P8) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) GLYCERIN (UNII: PDC6A3C0OX) NONI FRUIT (UNII: 7829X3G2X5) PHYTATE SODIUM (UNII: 88496G1ERL) FERROSOFERRIC OXIDE (UNII: XM0M87F357) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) XANTHAN GUM (UNII: TTV12P4NEE) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PROPANEDIOL (UNII: 5965N8W85T) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) COCO GLUCOSIDE (UNII: ICS790225B) WATER (UNII: 059QF0KO0R) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BENTONITE (UNII: A3N5ZCN45C) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ECTOINE (UNII: 7GXZ3858RY) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Product Characteristics Color brown (52N) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59735-917-02 1 in 1 BOX 11/22/2023 1 NDC:59735-917-01 35 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 11/22/2023 PROTECTINT 14N
homosalate, octisalate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59735-918 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 13.58 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength TOCOPHEROL (UNII: R0ZB2556P8) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) GLYCERIN (UNII: PDC6A3C0OX) NONI FRUIT (UNII: 7829X3G2X5) PHYTATE SODIUM (UNII: 88496G1ERL) FERROSOFERRIC OXIDE (UNII: XM0M87F357) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) XANTHAN GUM (UNII: TTV12P4NEE) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PROPANEDIOL (UNII: 5965N8W85T) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) COCO GLUCOSIDE (UNII: ICS790225B) WATER (UNII: 059QF0KO0R) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BENTONITE (UNII: A3N5ZCN45C) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ECTOINE (UNII: 7GXZ3858RY) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Product Characteristics Color white (14N) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59735-918-02 1 in 1 BOX 11/22/2023 1 NDC:59735-918-01 35 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 11/22/2023 PROTECTINT 40W
homosalate, octisalate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59735-919 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 13.58 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength TOCOPHEROL (UNII: R0ZB2556P8) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) GLYCERIN (UNII: PDC6A3C0OX) NONI FRUIT (UNII: 7829X3G2X5) PHYTATE SODIUM (UNII: 88496G1ERL) FERROSOFERRIC OXIDE (UNII: XM0M87F357) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) XANTHAN GUM (UNII: TTV12P4NEE) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PROPANEDIOL (UNII: 5965N8W85T) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) COCO GLUCOSIDE (UNII: ICS790225B) WATER (UNII: 059QF0KO0R) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BENTONITE (UNII: A3N5ZCN45C) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ECTOINE (UNII: 7GXZ3858RY) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Product Characteristics Color brown (40W) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59735-919-02 1 in 1 BOX 11/22/2023 1 NDC:59735-919-01 35 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 11/22/2023 Labeler - MANA PRODUCTS, INC. (078870292) Establishment Name Address ID/FEI Business Operations MANA PRODUCTS, INC. 078870292 manufacture(59735-911, 59735-918, 59735-906, 59735-913, 59735-912, 59735-907, 59735-914, 59735-908, 59735-909, 59735-919, 59735-916, 59735-915, 59735-917, 59735-910) Establishment Name Address ID/FEI Business Operations MANA Products,INC 032870270 manufacture(59735-911, 59735-918, 59735-906, 59735-913, 59735-912, 59735-907, 59735-914, 59735-908, 59735-909, 59735-919, 59735-916, 59735-915, 59735-917, 59735-910)