5-IN-1 TINTED FACE SUNSCREEN - FAIR- zinc oxide cream 5-IN-1 TINTED FACE SUNSCREEN - LIGHT- zinc oxide cream 5-IN-1 TINTED FACE SUNSCREEN - GOLDEN LIGHT- zinc oxide cream 5-IN-1 TINTED FACE SUNSCREEN - MEDIUM- zinc oxide cream

5-IN-1 TINTED FACE SUNSCREEN - MEDIUM by

Drug Labeling and Warnings

5-IN-1 TINTED FACE SUNSCREEN - MEDIUM by is a Otc medication manufactured, distributed, or labeled by Synchronicity Spa, Inc. DBA Suntegrity. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Zinc Oxide 20%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs

When using this product keep out of eyes. Rinse with water to remove.

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

Directions

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply 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 sleeved shirts, pants, hats and sunglasses

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Water, Caprylic/Capric Triglyceride, Polyglyceryl-3 Polyricinoleate, Glycerin, Hydrogenated Castor Oil, Sorbitan Sesquioleate, Hydrogenated Methyl Abietate, Stearyl/Octyldodecyl Citrate Crosspolymer, Magnesium Sulfate, Glyceryl Caprylate, Simmondsia Chinensis (Jojoba) Seed Oil, Cucumis Sativus (Cucumber) Extract, Camellia Sinensis (Green Tea) Extract, Helianthus Annuus (Sunflower) Seed Oil, Punica Granatum (Pomegranate) Seed Oil, Astaxanthin, Sodium Hyaluronate, Caprylhydroxamic Acid, Ethyhexylglycerin, Galactoarabinan, Iron Oxides (C.I. 77491, C.I. 77492, C.I. 77499).

Other information

• protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Fair

sun
tegrity®

5-IN-1 TINTED
SUNSCREEN MOISTURIZER

MOISTURIZE | HYDRATE | PROTECT | PRIME | COVER

BROAD SPECTRUM SPF 30

SPF
30

NON-NANO ZINC OXIDE

SHEER COVERAGE BB CREAM
DEWY FINISH

Antioxidants + Organic Oils
Reef-Friendly
Vegan

NET WT 2 OZ (56.7 g)

PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Light

sun
tegrity®

5-IN-1 TINTED
SUNSCREEN MOISTURIZER

MOISTURIZE | HYDRATE | PROTECT | PRIME | COVER

BROAD SPECTRUM SPF 30

SPF
30

NON-NANO ZINC OXIDE

SHEER COVERAGE BB CREAM
DEWY FINISH

Antioxidants + Organic Oils
Reef-Friendly
Vegan

NET WT 2 OZ (56.7 g)

PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Golden Light

sun
tegrity®

5-IN-1 TINTED
SUNSCREEN MOISTURIZER

MOISTURIZE | HYDRATE | PROTECT | PRIME | COVER

BROAD SPECTRUM SPF 30

SPF
30

NON-NANO ZINC OXIDE

SHEER COVERAGE BB CREAM
DEWY FINISH

Antioxidants + Organic Oils
Reef-Friendly
Vegan

NET WT 2 OZ (56.7 g)

PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Medium

sun
tegrity®

5-IN-1 TINTED
SUNSCREEN MOISTURIZER

MOISTURIZE | HYDRATE | PROTECT | PRIME | COVER

BROAD SPECTRUM SPF 30

SPF
30

NON-NANO ZINC OXIDE

SHEER COVERAGE BB CREAM
DEWY FINISH

Antioxidants + Organic Oils
Reef-Friendly
Vegan

NET WT 2 OZ (56.7 g)

INGREDIENTS AND APPEARANCE

5-IN-1 TINTED FACE SUNSCREEN - FAIR 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69949-051
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O)
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
JOJOBA OIL (UNII: 724GKU717M)
CUCUMBER (UNII: YY7C30VXJT)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SUNFLOWER OIL (UNII: 3W1JG795YI)
POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)
ASTAXANTHIN (UNII: 8XPW32PR7I)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GALACTOARABINAN (UNII: SL4SX1O487)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69949-051-01	56.7 g in 1 TUBE; Type 0: Not a Combination Product	07/26/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M020	07/01/2013

5-IN-1 TINTED FACE SUNSCREEN - LIGHT 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69949-052
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O)
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
JOJOBA OIL (UNII: 724GKU717M)
CUCUMBER (UNII: YY7C30VXJT)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SUNFLOWER OIL (UNII: 3W1JG795YI)
POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)
ASTAXANTHIN (UNII: 8XPW32PR7I)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GALACTOARABINAN (UNII: SL4SX1O487)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69949-052-01	56.7 g in 1 TUBE; Type 0: Not a Combination Product	07/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M020	07/01/2013

5-IN-1 TINTED FACE SUNSCREEN - GOLDEN LIGHT 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69949-053
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O)
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
JOJOBA OIL (UNII: 724GKU717M)
CUCUMBER (UNII: YY7C30VXJT)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SUNFLOWER OIL (UNII: 3W1JG795YI)
POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)
ASTAXANTHIN (UNII: 8XPW32PR7I)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GALACTOARABINAN (UNII: SL4SX1O487)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69949-053-01	56.7 g in 1 TUBE; Type 0: Not a Combination Product	10/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M020	10/01/2015

5-IN-1 TINTED FACE SUNSCREEN - MEDIUM 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69949-054
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O)
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
JOJOBA OIL (UNII: 724GKU717M)
CUCUMBER (UNII: YY7C30VXJT)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SUNFLOWER OIL (UNII: 3W1JG795YI)
POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)
ASTAXANTHIN (UNII: 8XPW32PR7I)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GALACTOARABINAN (UNII: SL4SX1O487)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69949-054-01	56.7 g in 1 TUBE; Type 0: Not a Combination Product	07/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M020	07/01/2013

Labeler - Synchronicity Spa, Inc. DBA Suntegrity (079164130)