SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN  5 FAIRFAX- zinc oxide lotion 
SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN  10 LARCHMONT- zinc oxide lotion 
SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN  13 LA CIENEGA- zinc oxide lotion 
SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN  15 MELROSE- zinc oxide lotion 
SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN  18 MONTANA- zinc oxide lotion 
SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN  20 MULHOLLAND- zinc oxide lotion 
SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN  25 OCEAN PARK- zinc oxide lotion 
SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN  30 PCH- zinc oxide lotion 
SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN  35 POINT DUME- zinc oxide lotion 
SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN  38 POMONA- zinc oxide lotion 
SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN  40 RUNYON- zinc oxide lotion 
SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN  45 SILVER LAKE- zinc oxide lotion 
SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN  50 SUNSET- zinc oxide lotion 
SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN  55 TEMESCAL- zinc oxide lotion 
SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN  60 THIRD ST- zinc oxide lotion 
SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN  65 TOPANGA- zinc oxide lotion 
SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN  70 VENICE- zinc oxide lotion 
Tower 28

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

SunnyDays Broad Spectrum SPF 30 Tinted Sunscreen

Drug Facts

Active ingredient

Zinc oxide, 12.6%

Purpose

Sunscreen

Uses

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.

Stop use and ask a doctor if skin rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

Water/Aqua/Eau, Isononyl Isononanoate, C9-12 Alkane, Butyloctyl Salicylate, Polyglyceryl-6 Polyricinoleate, Caprylic/Capric Triglyceride, Glycerin, Ethylhexyl Methoxycrylene, Trimethylsiloxysilicate, Mica, Polyglyceryl-2 Isostearate, Sodium Chloride, Phenoxyethanol, Disteardimonium Hectorite, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Coco-Caprylate/Caprate, Isostearic Acid, Lecithin, Polyglyceryl-6 Polyhydroxystearate, Jojoba Esters, Ethylhexylglycerin, Sodium Phytate, Aloe Barbadensis Leaf Water, Centella Asiatica Extract, Opuntia Tuna Fruit, Salvia Officinalis (Sage) Extract, May Contain (+/-): Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891).

DIST. BY
TOWER 28 BEAUTY, INC.
SANTA MONICA, CA 90405

PRINCIPAL DISPLAY PANEL - 30 ML Tube Box - 5 Fairfax

SunnyDays

TOWER 28™

SPF 30

BROAD SPECTRUM
SPF 30 MINERAL
TINTED SUNSCREEN

30 ML / 1 FL OZ.

Principal Display Panel - 30 ML Tube Box - 5 Fairfax

PRINCIPAL DISPLAY PANEL - 30 ML Tube Box - 10 Larchmont

SunnyDays

TOWER 28™

SPF 30

BROAD SPECTRUM
SPF 30 MINERAL
TINTED SUNSCREEN

30 ML / 1 FL OZ.

Principal Display Panel - 30 ML Tube Box - 10 Larchmont

PRINCIPAL DISPLAY PANEL - 30 ML Tube Box - 13 La Cienega

SunnyDays

TOWER 28™

SPF 30

BROAD SPECTRUM
SPF 30 MINERAL
TINTED SUNSCREEN

30 ML / 1 FL OZ.

PRINCIPAL DISPLAY PANEL - 30 ML Tube Box - 13 La Cienega

PRINCIPAL DISPLAY PANEL - 30 ML Tube Box - 15 Melrose

SunnyDays

TOWER 28™

SPF 30

BROAD SPECTRUM
SPF 30 MINERAL
TINTED SUNSCREEN

30 ML / 1 FL OZ.

Principal Display Panel - 30 ML Tube Box - 15 Melrose

PRINCIPAL DISPLAY PANEL - 30 ML Tube Box - 18 Montana

SunnyDays

TOWER 28™

SPF 30

BROAD SPECTRUM
SPF 30 MINERAL
TINTED SUNSCREEN

30 ML / 1 FL OZ.

PRINCIPAL DISPLAY PANEL - 30 ML Tube Box - 18 Montana

PRINCIPAL DISPLAY PANEL - 30 ML Tube Box - 20 Mulholland

SunnyDays

TOWER 28™

SPF 30

BROAD SPECTRUM
SPF 30 MINERAL
TINTED SUNSCREEN

30 ML / 1 FL OZ.

Principal Display Panel - 30 ML Tube Box - 20 Mulholland

PRINCIPAL DISPLAY PANEL - 30 ML Tube Box - 25 Ocean Park

SunnyDays

TOWER 28™

SPF 30

BROAD SPECTRUM
SPF 30 MINERAL
TINTED SUNSCREEN

30 ML / 1 FL OZ.

Principal Display Panel - 30 ML Tube Box - 25 Ocean Park

PRINCIPAL DISPLAY PANEL - 30 ML Tube Box - 30 PCH

SunnyDays

TOWER 28™

SPF 30

BROAD SPECTRUM
SPF 30 MINERAL
TINTED SUNSCREEN

30 ML / 1 FL OZ.

Principal Display Panel - 30 ML Tube Box - 30 PCH

PRINCIPAL DISPLAY PANEL - 30 ML Tube Box - 35 Point Dume

SunnyDays

TOWER 28™

SPF 30

BROAD SPECTRUM
SPF 30 MINERAL
TINTED SUNSCREEN

30 ML / 1 FL OZ.

Principal Display Panel - 30 ML Tube Box - 35 Point Dume

PRINCIPAL DISPLAY PANEL - 30 ML Tube Box - 38 Pomona

SunnyDays

TOWER 28™

SPF 30

BROAD SPECTRUM
SPF 30 MINERAL
TINTED SUNSCREEN

30 ML / 1 FL OZ.

PRINCIPAL DISPLAY PANEL - 30 ML Tube Box - 38 Pomona

PRINCIPAL DISPLAY PANEL - 30 ML Tube Box - 40 Runyon

SunnyDays

TOWER 28™

SPF 30

BROAD SPECTRUM
SPF 30 MINERAL
TINTED SUNSCREEN

30 ML / 1 FL OZ.

Principal Display Panel - 30 ML Tube Box -  40 Runyon

PRINCIPAL DISPLAY PANEL - 30 ML Tube Box - 45 Silver Lake

SunnyDays

TOWER 28™

SPF 30

BROAD SPECTRUM
SPF 30 MINERAL
TINTED SUNSCREEN

30 ML / 1 FL OZ.

Principal Display Panel - 30 ML Tube Box -  45 Silver Lake

PRINCIPAL DISPLAY PANEL - 30 ML Tube Box - 50 Sunset

SunnyDays

TOWER 28™

SPF 30

BROAD SPECTRUM
SPF 30 MINERAL
TINTED SUNSCREEN

30 ML / 1 FL OZ.

Principal Display Panel - 30 ML Tube Box -  50 Sunset

PRINCIPAL DISPLAY PANEL - 30 ML Tube Box - 55 Temescal

SunnyDays

TOWER 28™

SPF 30

BROAD SPECTRUM
SPF 30 MINERAL
TINTED SUNSCREEN

30 ML / 1 FL OZ.

Principal Display Panel - 30 ML Tube Box -  55 Temescal

PRINCIPAL DISPLAY PANEL - 30 ML Tube Box - 60 Third St

SunnyDays

TOWER 28™

SPF 30

BROAD SPECTRUM
SPF 30 MINERAL
TINTED SUNSCREEN

30 ML / 1 FL OZ.

Principal Display Panel - 30 ML Tube Box -  60 Third St

PRINCIPAL DISPLAY PANEL - 30 ML Tube Box - 65 Topanga

SunnyDays

TOWER 28™

SPF 30

BROAD SPECTRUM
SPF 30 MINERAL
TINTED SUNSCREEN

30 ML / 1 FL OZ.

Principal Display Panel - 30 ML Tube Box -  65 Topanga

PRINCIPAL DISPLAY PANEL - 30 ML Tube Box - 70 Venice

SunnyDays

TOWER 28™

SPF 30

BROAD SPECTRUM
SPF 30 MINERAL
TINTED SUNSCREEN

30 ML / 1 FL OZ.

Principal Display Panel - 30 ML Tube Box -  70 Venice
SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN   5 FAIRFAX
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81899-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide126 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Isononyl Isononanoate (UNII: S4V5BS6GCX)  
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
Polyglyceryl-6 Polyricinoleate (UNII: YPM0ZOC2HR)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Glycerin (UNII: PDC6A3C0OX)  
Ethylhexyl Methoxycrylene (UNII: S3KFG6Q5X8)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
Mica (UNII: V8A1AW0880)  
Polyglyceryl-2 Isostearate (UNII: 7B8OE71MQC)  
Sodium Chloride (UNII: 451W47IQ8X)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Disteardimonium Hectorite (UNII: X687XDK09L)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
Isostearic Acid (UNII: X33R8U0062)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
Ethylhexylglycerin (UNII: 147D247K3P)  
PHYTATE SODIUM (UNII: 88496G1ERL)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)  
Opuntia Tuna Fruit (UNII: 75UY509K9B)  
SALVIA OFFICINALIS ROOT (UNII: 236QY0A1BL)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBROWN (Fair with pink undertones) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81899-005-011 in 1 BOX08/15/2021
130 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35208/15/2021
SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN   10 LARCHMONT
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81899-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide126 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Isononyl Isononanoate (UNII: S4V5BS6GCX)  
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
Polyglyceryl-6 Polyricinoleate (UNII: YPM0ZOC2HR)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Glycerin (UNII: PDC6A3C0OX)  
Ethylhexyl Methoxycrylene (UNII: S3KFG6Q5X8)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
Mica (UNII: V8A1AW0880)  
Polyglyceryl-2 Isostearate (UNII: 7B8OE71MQC)  
Sodium Chloride (UNII: 451W47IQ8X)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Disteardimonium Hectorite (UNII: X687XDK09L)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
Isostearic Acid (UNII: X33R8U0062)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
Ethylhexylglycerin (UNII: 147D247K3P)  
PHYTATE SODIUM (UNII: 88496G1ERL)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)  
Opuntia Tuna Fruit (UNII: 75UY509K9B)  
SALVIA OFFICINALIS ROOT (UNII: 236QY0A1BL)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBROWN (Light with yellow undertones) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81899-010-011 in 1 BOX08/15/2021
130 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35208/15/2021
SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN   13 LA CIENEGA
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81899-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide126 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Isononyl Isononanoate (UNII: S4V5BS6GCX)  
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
Polyglyceryl-6 Polyricinoleate (UNII: YPM0ZOC2HR)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Glycerin (UNII: PDC6A3C0OX)  
Ethylhexyl Methoxycrylene (UNII: S3KFG6Q5X8)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
Mica (UNII: V8A1AW0880)  
Polyglyceryl-2 Isostearate (UNII: 7B8OE71MQC)  
Sodium Chloride (UNII: 451W47IQ8X)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Disteardimonium Hectorite (UNII: X687XDK09L)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
Isostearic Acid (UNII: X33R8U0062)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
Ethylhexylglycerin (UNII: 147D247K3P)  
PHYTATE SODIUM (UNII: 88496G1ERL)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)  
Opuntia Tuna Fruit (UNII: 75UY509K9B)  
SALVIA OFFICINALIS ROOT (UNII: 236QY0A1BL)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBROWN (Light with neutral undertone) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81899-013-001 in 1 BOX01/24/2023
130 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/24/2023
SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN   15 MELROSE
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81899-015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide126 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Isononyl Isononanoate (UNII: S4V5BS6GCX)  
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
Polyglyceryl-6 Polyricinoleate (UNII: YPM0ZOC2HR)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Glycerin (UNII: PDC6A3C0OX)  
Ethylhexyl Methoxycrylene (UNII: S3KFG6Q5X8)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
Mica (UNII: V8A1AW0880)  
Polyglyceryl-2 Isostearate (UNII: 7B8OE71MQC)  
Sodium Chloride (UNII: 451W47IQ8X)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Disteardimonium Hectorite (UNII: X687XDK09L)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
Isostearic Acid (UNII: X33R8U0062)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
Ethylhexylglycerin (UNII: 147D247K3P)  
PHYTATE SODIUM (UNII: 88496G1ERL)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)  
Opuntia Tuna Fruit (UNII: 75UY509K9B)  
SALVIA OFFICINALIS ROOT (UNII: 236QY0A1BL)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBROWN (Light with neutral undertone) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81899-015-011 in 1 BOX08/15/2021
130 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35208/15/2021
SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN   18 MONTANA
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81899-018
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide126 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Isononyl Isononanoate (UNII: S4V5BS6GCX)  
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
Polyglyceryl-6 Polyricinoleate (UNII: YPM0ZOC2HR)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Glycerin (UNII: PDC6A3C0OX)  
Ethylhexyl Methoxycrylene (UNII: S3KFG6Q5X8)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
Mica (UNII: V8A1AW0880)  
Polyglyceryl-2 Isostearate (UNII: 7B8OE71MQC)  
Sodium Chloride (UNII: 451W47IQ8X)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Disteardimonium Hectorite (UNII: X687XDK09L)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
Isostearic Acid (UNII: X33R8U0062)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
Ethylhexylglycerin (UNII: 147D247K3P)  
PHYTATE SODIUM (UNII: 88496G1ERL)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)  
Opuntia Tuna Fruit (UNII: 75UY509K9B)  
SALVIA OFFICINALIS ROOT (UNII: 236QY0A1BL)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBROWN (Light with peach undertones) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81899-018-021 in 1 BOX01/24/2023
130 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/24/2023
SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN   20 MULHOLLAND
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81899-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide126 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Isononyl Isononanoate (UNII: S4V5BS6GCX)  
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
Polyglyceryl-6 Polyricinoleate (UNII: YPM0ZOC2HR)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Glycerin (UNII: PDC6A3C0OX)  
Ethylhexyl Methoxycrylene (UNII: S3KFG6Q5X8)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
Mica (UNII: V8A1AW0880)  
Polyglyceryl-2 Isostearate (UNII: 7B8OE71MQC)  
Sodium Chloride (UNII: 451W47IQ8X)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Disteardimonium Hectorite (UNII: X687XDK09L)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
Isostearic Acid (UNII: X33R8U0062)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
Ethylhexylglycerin (UNII: 147D247K3P)  
PHYTATE SODIUM (UNII: 88496G1ERL)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)  
Opuntia Tuna Fruit (UNII: 75UY509K9B)  
SALVIA OFFICINALIS ROOT (UNII: 236QY0A1BL)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBROWN (Light with warm undertones) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81899-020-011 in 1 BOX08/15/2021
130 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35208/15/2021
SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN   25 OCEAN PARK
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81899-025
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide126 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Isononyl Isononanoate (UNII: S4V5BS6GCX)  
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
Polyglyceryl-6 Polyricinoleate (UNII: YPM0ZOC2HR)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Glycerin (UNII: PDC6A3C0OX)  
Ethylhexyl Methoxycrylene (UNII: S3KFG6Q5X8)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
Mica (UNII: V8A1AW0880)  
Polyglyceryl-2 Isostearate (UNII: 7B8OE71MQC)  
Sodium Chloride (UNII: 451W47IQ8X)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Disteardimonium Hectorite (UNII: X687XDK09L)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
Isostearic Acid (UNII: X33R8U0062)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
Ethylhexylglycerin (UNII: 147D247K3P)  
PHYTATE SODIUM (UNII: 88496G1ERL)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)  
Opuntia Tuna Fruit (UNII: 75UY509K9B)  
SALVIA OFFICINALIS ROOT (UNII: 236QY0A1BL)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBROWN (Medium skin with neutral undertones) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81899-025-011 in 1 BOX08/15/2021
130 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35208/15/2021
SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN   30 PCH
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81899-030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide126 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Isononyl Isononanoate (UNII: S4V5BS6GCX)  
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
Polyglyceryl-6 Polyricinoleate (UNII: YPM0ZOC2HR)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Glycerin (UNII: PDC6A3C0OX)  
Ethylhexyl Methoxycrylene (UNII: S3KFG6Q5X8)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
Mica (UNII: V8A1AW0880)  
Polyglyceryl-2 Isostearate (UNII: 7B8OE71MQC)  
Sodium Chloride (UNII: 451W47IQ8X)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Disteardimonium Hectorite (UNII: X687XDK09L)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
Isostearic Acid (UNII: X33R8U0062)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
Ethylhexylglycerin (UNII: 147D247K3P)  
PHYTATE SODIUM (UNII: 88496G1ERL)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)  
Opuntia Tuna Fruit (UNII: 75UY509K9B)  
SALVIA OFFICINALIS ROOT (UNII: 236QY0A1BL)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBROWN (Medium with golden warm undertones) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81899-030-011 in 1 BOX08/15/2021
130 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35208/15/2021
SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN   35 POINT DUME
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81899-035
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide126 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Isononyl Isononanoate (UNII: S4V5BS6GCX)  
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
Polyglyceryl-6 Polyricinoleate (UNII: YPM0ZOC2HR)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Glycerin (UNII: PDC6A3C0OX)  
Ethylhexyl Methoxycrylene (UNII: S3KFG6Q5X8)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
Mica (UNII: V8A1AW0880)  
Polyglyceryl-2 Isostearate (UNII: 7B8OE71MQC)  
Sodium Chloride (UNII: 451W47IQ8X)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Disteardimonium Hectorite (UNII: X687XDK09L)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
Isostearic Acid (UNII: X33R8U0062)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
Ethylhexylglycerin (UNII: 147D247K3P)  
PHYTATE SODIUM (UNII: 88496G1ERL)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)  
Opuntia Tuna Fruit (UNII: 75UY509K9B)  
SALVIA OFFICINALIS ROOT (UNII: 236QY0A1BL)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBROWN (Medium with warm undertones) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81899-035-011 in 1 BOX08/15/2021
130 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35208/15/2021
SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN   38 POMONA
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81899-038
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide126 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Isononyl Isononanoate (UNII: S4V5BS6GCX)  
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
Polyglyceryl-6 Polyricinoleate (UNII: YPM0ZOC2HR)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Glycerin (UNII: PDC6A3C0OX)  
Ethylhexyl Methoxycrylene (UNII: S3KFG6Q5X8)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
Mica (UNII: V8A1AW0880)  
Polyglyceryl-2 Isostearate (UNII: 7B8OE71MQC)  
Sodium Chloride (UNII: 451W47IQ8X)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Disteardimonium Hectorite (UNII: X687XDK09L)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
Isostearic Acid (UNII: X33R8U0062)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
Ethylhexylglycerin (UNII: 147D247K3P)  
PHYTATE SODIUM (UNII: 88496G1ERL)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)  
Opuntia Tuna Fruit (UNII: 75UY509K9B)  
SALVIA OFFICINALIS ROOT (UNII: 236QY0A1BL)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBROWN (Medium with golden undertones) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81899-038-021 in 1 BOX01/24/2023
130 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/24/2023
SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN   40 RUNYON
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81899-040
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide126 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Isononyl Isononanoate (UNII: S4V5BS6GCX)  
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
Polyglyceryl-6 Polyricinoleate (UNII: YPM0ZOC2HR)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Glycerin (UNII: PDC6A3C0OX)  
Ethylhexyl Methoxycrylene (UNII: S3KFG6Q5X8)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
Mica (UNII: V8A1AW0880)  
Polyglyceryl-2 Isostearate (UNII: 7B8OE71MQC)  
Sodium Chloride (UNII: 451W47IQ8X)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Disteardimonium Hectorite (UNII: X687XDK09L)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
Isostearic Acid (UNII: X33R8U0062)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
Ethylhexylglycerin (UNII: 147D247K3P)  
PHYTATE SODIUM (UNII: 88496G1ERL)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)  
Opuntia Tuna Fruit (UNII: 75UY509K9B)  
SALVIA OFFICINALIS ROOT (UNII: 236QY0A1BL)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBROWN (Tan with warm undertones) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81899-040-011 in 1 BOX08/15/2021
130 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35208/15/2021
SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN   45 SILVER LAKE
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81899-045
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide126 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Isononyl Isononanoate (UNII: S4V5BS6GCX)  
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
Polyglyceryl-6 Polyricinoleate (UNII: YPM0ZOC2HR)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Glycerin (UNII: PDC6A3C0OX)  
Ethylhexyl Methoxycrylene (UNII: S3KFG6Q5X8)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
Mica (UNII: V8A1AW0880)  
Polyglyceryl-2 Isostearate (UNII: 7B8OE71MQC)  
Sodium Chloride (UNII: 451W47IQ8X)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Disteardimonium Hectorite (UNII: X687XDK09L)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
Isostearic Acid (UNII: X33R8U0062)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
Ethylhexylglycerin (UNII: 147D247K3P)  
PHYTATE SODIUM (UNII: 88496G1ERL)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)  
Opuntia Tuna Fruit (UNII: 75UY509K9B)  
SALVIA OFFICINALIS ROOT (UNII: 236QY0A1BL)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBROWN (Tan with neutral undertones) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81899-045-011 in 1 BOX08/15/2021
130 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35208/15/2021
SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN   50 SUNSET
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81899-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide126 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Isononyl Isononanoate (UNII: S4V5BS6GCX)  
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
Polyglyceryl-6 Polyricinoleate (UNII: YPM0ZOC2HR)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Glycerin (UNII: PDC6A3C0OX)  
Ethylhexyl Methoxycrylene (UNII: S3KFG6Q5X8)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
Mica (UNII: V8A1AW0880)  
Polyglyceryl-2 Isostearate (UNII: 7B8OE71MQC)  
Sodium Chloride (UNII: 451W47IQ8X)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Disteardimonium Hectorite (UNII: X687XDK09L)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
Isostearic Acid (UNII: X33R8U0062)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
Ethylhexylglycerin (UNII: 147D247K3P)  
PHYTATE SODIUM (UNII: 88496G1ERL)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)  
Opuntia Tuna Fruit (UNII: 75UY509K9B)  
SALVIA OFFICINALIS ROOT (UNII: 236QY0A1BL)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBROWN (Tan with golden undertones) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81899-050-011 in 1 BOX08/15/2021
130 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35208/15/2021
SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN   55 TEMESCAL
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81899-055
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide126 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Isononyl Isononanoate (UNII: S4V5BS6GCX)  
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
Polyglyceryl-6 Polyricinoleate (UNII: YPM0ZOC2HR)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Glycerin (UNII: PDC6A3C0OX)  
Ethylhexyl Methoxycrylene (UNII: S3KFG6Q5X8)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
Mica (UNII: V8A1AW0880)  
Polyglyceryl-2 Isostearate (UNII: 7B8OE71MQC)  
Sodium Chloride (UNII: 451W47IQ8X)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Disteardimonium Hectorite (UNII: X687XDK09L)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
Isostearic Acid (UNII: X33R8U0062)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
Ethylhexylglycerin (UNII: 147D247K3P)  
PHYTATE SODIUM (UNII: 88496G1ERL)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)  
Opuntia Tuna Fruit (UNII: 75UY509K9B)  
SALVIA OFFICINALIS ROOT (UNII: 236QY0A1BL)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBROWN (Deep with warm undertones) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81899-055-011 in 1 BOX08/15/2021
130 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35208/15/2021
SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN   60 THIRD ST
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81899-060
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide126 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Isononyl Isononanoate (UNII: S4V5BS6GCX)  
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
Polyglyceryl-6 Polyricinoleate (UNII: YPM0ZOC2HR)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Glycerin (UNII: PDC6A3C0OX)  
Ethylhexyl Methoxycrylene (UNII: S3KFG6Q5X8)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
Mica (UNII: V8A1AW0880)  
Polyglyceryl-2 Isostearate (UNII: 7B8OE71MQC)  
Sodium Chloride (UNII: 451W47IQ8X)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Disteardimonium Hectorite (UNII: X687XDK09L)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
Isostearic Acid (UNII: X33R8U0062)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
Ethylhexylglycerin (UNII: 147D247K3P)  
PHYTATE SODIUM (UNII: 88496G1ERL)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)  
Opuntia Tuna Fruit (UNII: 75UY509K9B)  
SALVIA OFFICINALIS ROOT (UNII: 236QY0A1BL)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBROWN (Deep with neutral undertones) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81899-060-011 in 1 BOX08/15/2021
130 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35208/15/2021
SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN   65 TOPANGA
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81899-065
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide126 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Isononyl Isononanoate (UNII: S4V5BS6GCX)  
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
Polyglyceryl-6 Polyricinoleate (UNII: YPM0ZOC2HR)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Glycerin (UNII: PDC6A3C0OX)  
Ethylhexyl Methoxycrylene (UNII: S3KFG6Q5X8)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
Mica (UNII: V8A1AW0880)  
Polyglyceryl-2 Isostearate (UNII: 7B8OE71MQC)  
Sodium Chloride (UNII: 451W47IQ8X)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Disteardimonium Hectorite (UNII: X687XDK09L)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
Isostearic Acid (UNII: X33R8U0062)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
Ethylhexylglycerin (UNII: 147D247K3P)  
PHYTATE SODIUM (UNII: 88496G1ERL)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)  
Opuntia Tuna Fruit (UNII: 75UY509K9B)  
SALVIA OFFICINALIS ROOT (UNII: 236QY0A1BL)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBROWN (Dark with warm undertones) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81899-065-011 in 1 BOX08/15/2021
130 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35208/15/2021
SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN   70 VENICE
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81899-070
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide126 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Isononyl Isononanoate (UNII: S4V5BS6GCX)  
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
Polyglyceryl-6 Polyricinoleate (UNII: YPM0ZOC2HR)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Glycerin (UNII: PDC6A3C0OX)  
Ethylhexyl Methoxycrylene (UNII: S3KFG6Q5X8)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
Mica (UNII: V8A1AW0880)  
Polyglyceryl-2 Isostearate (UNII: 7B8OE71MQC)  
Sodium Chloride (UNII: 451W47IQ8X)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Disteardimonium Hectorite (UNII: X687XDK09L)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
Isostearic Acid (UNII: X33R8U0062)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
Ethylhexylglycerin (UNII: 147D247K3P)  
PHYTATE SODIUM (UNII: 88496G1ERL)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)  
Opuntia Tuna Fruit (UNII: 75UY509K9B)  
SALVIA OFFICINALIS ROOT (UNII: 236QY0A1BL)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBROWN (Dark with cooler undertones) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81899-070-011 in 1 BOX08/15/2021
130 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35208/15/2021
Labeler - Tower 28 (117206079)

Revised: 1/2023
Document Id: b2394e8b-7845-4a2c-a166-b4bed4cfc163
Set id: 108851ac-3812-4c02-a04a-9f9a7f529ed6
Version: 2
Effective Time: 20230131
 
Tower 28