DailyMed - 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

NDC Code(s): 75936-622-01, 75936-622-02, 75936-624-01, 75936-624-02, view more
75936-625-01, 75936-625-02, 75936-626-01, 75936-626-02, 75936-627-01, 75936-627-02, 75936-628-01, 75936-628-02, 75936-629-01, 75936-629-02, 75936-630-01, 75936-630-02, 75936-631-01, 75936-631-02, 75936-632-01, 75936-632-02, 75936-633-01, 75936-633-02, 75936-634-01, 75936-634-02, 75936-635-01, 75936-635-02, 75936-636-01, 75936-636-02
Packager: Supergoop, LLC

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated October 18, 2023

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: Zinc Oxide 13.58%, Homosalate 7.0%, Octisalate 5.0%
PURPOSE

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

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
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

Protec(tint)

Daily SPF Tint

SPF 50

Broad Spectrum Tinted

Sunscreen SPF 50

1.18 fl. oz. / 35 ml.

SHADE LABELS

INGREDIENTS AND APPEARANCE

PROTECTINT 20C
homosalate, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75936-625
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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 (20C)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75936-625-02	1 in 1 BOX	11/22/2023
1	NDC:75936-625-01	35 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	11/22/2023

PROTECTINT 26W
homosalate, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75936-628
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75936-628-02	1 in 1 BOX	11/22/2023
1	NDC:75936-628-01	35 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	11/22/2023

PROTECTINT 32N
homosalate, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75936-630
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75936-630-02	1 in 1 BOX	11/22/2023
1	NDC:75936-630-01	35 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	11/22/2023

PROTECTINT 34C
homosalate, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75936-631
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75936-631-02	1 in 1 BOX	11/22/2023
1	NDC:75936-631-01	35 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	11/22/2023

PROTECTINT 58W
homosalate, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75936-636
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75936-636-02	1 in 1 BOX	11/22/2023
1	NDC:75936-636-01	35 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	11/22/2023

PROTECTINT 10N
homosalate, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75936-622
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75936-622-02	1 in 1 BOX	11/22/2023
1	NDC:75936-622-01	35 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	11/22/2023

PROTECTINT 24N
homosalate, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75936-627
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75936-627-02	1 in 1 BOX	11/22/2023
1	NDC:75936-627-01	35 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	11/22/2023

PROTECTINT 22W
homosalate, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75936-626
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75936-626-02	1 in 1 BOX	11/22/2023
1	NDC:75936-626-01	35 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	11/22/2023

PROTECTINT 30W
homosalate, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75936-629
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75936-629-02	1 in 1 BOX	11/22/2023
1	NDC:75936-629-01	35 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	11/22/2023

PROTECTINT 46N
homosalate, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75936-634
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75936-634-02	1 in 1 BOX	11/22/2023
1	NDC:75936-634-01	35 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	11/22/2023

PROTECTINT 42C
homosalate, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75936-633
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75936-633-02	1 in 1 BOX	11/22/2023
1	NDC:75936-633-01	35 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	11/22/2023

PROTECTINT 52N
homosalate, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75936-635
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75936-635-02	1 in 1 BOX	11/22/2023
1	NDC:75936-635-01	35 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	11/22/2023

PROTECTINT 14N
homosalate, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75936-624
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75936-624-02	1 in 1 BOX	11/22/2023
1	NDC:75936-624-01	35 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	11/22/2023

PROTECTINT 40W
homosalate, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75936-632
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75936-632-02	1 in 1 BOX	11/22/2023
1	NDC:75936-632-01	35 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	11/22/2023

Labeler - Supergoop, LLC (117061743)

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	NDC
1	75936-622-01
2	75936-622-02
3	75936-624-01
4	75936-624-02
5	75936-625-01
6	75936-625-02
7	75936-626-01
8	75936-626-02
9	75936-627-01
10	75936-627-02
11	75936-628-01
12	75936-628-02
13	75936-629-01
14	75936-629-02
15	75936-630-01
16	75936-630-02
17	75936-631-01
18	75936-631-02
19	75936-632-01
20	75936-632-02
21	75936-633-01
22	75936-633-02
23	75936-634-01
24	75936-634-02
25	75936-635-01
26	75936-635-02
27	75936-636-01
28	75936-636-02

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