Label: 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
-
NDC Code(s):
81899-005-01,
81899-010-01,
81899-013-00,
81899-015-01, view more81899-018-02, 81899-020-01, 81899-025-01, 81899-030-01, 81899-035-01, 81899-038-02, 81899-040-01, 81899-045-01, 81899-050-01, 81899-055-01, 81899-060-01, 81899-065-01, 81899-070-01
- Packager: Tower 28
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 31, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
-
Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
- Warnings
-
Directions
- apply liberally and evenly 15 minutes before sun exposure.
- reapply at least every 2 hours
- use a water-resistant sunscreen if swimming or sweating:
- immediately after towel drying
- at least every 2 hours
- children under 6 months: Ask a doctor
-
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. – 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
- 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).
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 ML Tube Box - 5 Fairfax
- PRINCIPAL DISPLAY PANEL - 30 ML Tube Box - 10 Larchmont
- PRINCIPAL DISPLAY PANEL - 30 ML Tube Box - 13 La Cienega
- PRINCIPAL DISPLAY PANEL - 30 ML Tube Box - 15 Melrose
- PRINCIPAL DISPLAY PANEL - 30 ML Tube Box - 18 Montana
- PRINCIPAL DISPLAY PANEL - 30 ML Tube Box - 20 Mulholland
- PRINCIPAL DISPLAY PANEL - 30 ML Tube Box - 25 Ocean Park
- PRINCIPAL DISPLAY PANEL - 30 ML Tube Box - 30 PCH
- PRINCIPAL DISPLAY PANEL - 30 ML Tube Box - 35 Point Dume
- PRINCIPAL DISPLAY PANEL - 30 ML Tube Box - 38 Pomona
- PRINCIPAL DISPLAY PANEL - 30 ML Tube Box - 40 Runyon
- PRINCIPAL DISPLAY PANEL - 30 ML Tube Box - 45 Silver Lake
- PRINCIPAL DISPLAY PANEL - 30 ML Tube Box - 50 Sunset
- PRINCIPAL DISPLAY PANEL - 30 ML Tube Box - 55 Temescal
- PRINCIPAL DISPLAY PANEL - 30 ML Tube Box - 60 Third St
- PRINCIPAL DISPLAY PANEL - 30 ML Tube Box - 65 Topanga
- PRINCIPAL DISPLAY PANEL - 30 ML Tube Box - 70 Venice
-
INGREDIENTS AND APPEARANCE
SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN 5 FAIRFAX
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81899-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 126 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Color BROWN (Fair with pink undertones) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81899-005-01 1 in 1 BOX 08/15/2021 1 30 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 08/15/2021 SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN 10 LARCHMONT
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81899-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 126 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Color BROWN (Light with yellow undertones) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81899-010-01 1 in 1 BOX 08/15/2021 1 30 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 08/15/2021 SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN 13 LA CIENEGA
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81899-013 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 126 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Color BROWN (Light with neutral undertone) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81899-013-00 1 in 1 BOX 01/24/2023 1 30 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/24/2023 SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN 15 MELROSE
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81899-015 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 126 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Color BROWN (Light with neutral undertone) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81899-015-01 1 in 1 BOX 08/15/2021 1 30 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 08/15/2021 SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN 18 MONTANA
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81899-018 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 126 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Color BROWN (Light with peach undertones) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81899-018-02 1 in 1 BOX 01/24/2023 1 30 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/24/2023 SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN 20 MULHOLLAND
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81899-020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 126 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Color BROWN (Light with warm undertones) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81899-020-01 1 in 1 BOX 08/15/2021 1 30 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 08/15/2021 SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN 25 OCEAN PARK
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81899-025 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 126 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Color BROWN (Medium skin with neutral undertones) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81899-025-01 1 in 1 BOX 08/15/2021 1 30 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 08/15/2021 SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN 30 PCH
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81899-030 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 126 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Color BROWN (Medium with golden warm undertones) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81899-030-01 1 in 1 BOX 08/15/2021 1 30 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 08/15/2021 SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN 35 POINT DUME
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81899-035 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 126 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Color BROWN (Medium with warm undertones) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81899-035-01 1 in 1 BOX 08/15/2021 1 30 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 08/15/2021 SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN 38 POMONA
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81899-038 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 126 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Color BROWN (Medium with golden undertones) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81899-038-02 1 in 1 BOX 01/24/2023 1 30 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/24/2023 SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN 40 RUNYON
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81899-040 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 126 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Color BROWN (Tan with warm undertones) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81899-040-01 1 in 1 BOX 08/15/2021 1 30 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 08/15/2021 SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN 45 SILVER LAKE
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81899-045 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 126 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Color BROWN (Tan with neutral undertones) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81899-045-01 1 in 1 BOX 08/15/2021 1 30 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 08/15/2021 SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN 50 SUNSET
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81899-050 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 126 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Color BROWN (Tan with golden undertones) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81899-050-01 1 in 1 BOX 08/15/2021 1 30 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 08/15/2021 SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN 55 TEMESCAL
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81899-055 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 126 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Color BROWN (Deep with warm undertones) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81899-055-01 1 in 1 BOX 08/15/2021 1 30 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 08/15/2021 SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN 60 THIRD ST
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81899-060 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 126 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Color BROWN (Deep with neutral undertones) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81899-060-01 1 in 1 BOX 08/15/2021 1 30 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 08/15/2021 SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN 65 TOPANGA
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81899-065 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 126 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Color BROWN (Dark with warm undertones) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81899-065-01 1 in 1 BOX 08/15/2021 1 30 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 08/15/2021 SUNNYDAYS BROAD SPECTRUM SPF 30 TINTED SUNSCREEN 70 VENICE
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81899-070 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 126 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Color BROWN (Dark with cooler undertones) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81899-070-01 1 in 1 BOX 08/15/2021 1 30 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 08/15/2021 Labeler - Tower 28 (117206079)
