FDA.reportPublic FDA data

IMPECCABLE SKIN - MOCHA

Manufacturer
Synchronicity Spa, Inc. DBA Suntegrity
Effective date
2024-11-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:39:22

Label at a glance#

ProductIMPECCABLE SKIN - IVORY
Active ingredientZINC OXIDE
Label structure15 sections

Indications and 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

Dosage and administration

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: li...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 15%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - WHEN USING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Purified Water, Caprylic/Capric Triglyceride, C13-15 Alkane, Glycerin, Lauroyl Lysine, Polyglyceryl-2 Oleate, Polyhydroxystearic Acid, C12-15 Alkyl Benzoate, Stearalkonium Hectorite, Leuconostoc/Radish Root Ferment Filtrate, Dipalmitoyl Hydroxyproline, Tetrahexyldecyl Ascorbate, Tocopherol, Sambucus Nigra Fruit Extract, Kappaphycus Alvarezii Extract, Caesalpinia Spinosa Fruit Extract, Melanin, Bisabolol, Hyaluronic Acid, Camellia Sinensis Leaf Extract, Phospholipids, Polyglyceryl-2 Stearate, Lactobacillus, Cocos Nucifera (Coconut) Fruit Extract, Ethylhexylglycerin, Sodium Chloride, Propylene Carbonate, Isopropyl Titanium Triisostearate, Titanium Dioxide (C.I.77891), Iron Oxides (C.I.77492, C.I. 77491, C.I.77499)

Other information

STORAGE AND HANDLING SECTION

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

PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Ivory

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sun
tegrity®

IMPECCABLE
SKIN
SUNSCREEN FOUNDATION

BROAD SPECTRUM SPF 30

SPF
30

NON-NANO ZINC OXIDE

MEDIUM COVERAGE CC CREAM
SATIN FINISH

Peptides & Vitamins C + E
Blue Light Protection
Oil Free | Vegan | Reef Friendly

NET WT 2 OZ (56.7 g)

PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Ivory
PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Ivory

PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Buff

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sun
tegrity®

IMPECCABLE
SKIN
SUNSCREEN FOUNDATION

BROAD SPECTRUM SPF 30

SPF
30

NON-NANO ZINC OXIDE

MEDIUM COVERAGE CC CREAM
SATIN FINISH

Peptides & Vitamins C + E
Blue Light Protection
Oil Free | Vegan | Reef Friendly

NET WT 2 OZ (56.7 g)

PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Buff
PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Buff

PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Sand

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sun
tegrity®

IMPECCABLE
SKIN
SUNSCREEN FOUNDATION

BROAD SPECTRUM SPF 30

SPF
30

NON-NANO ZINC OXIDE

MEDIUM COVERAGE CC CREAM
SATIN FINISH

Peptides & Vitamins C + E
Blue Light Protection
Oil Free | Vegan | Reef Friendly

NET WT 2 OZ (56.7 g)

PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Sand
PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Sand

PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Tan

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sun
tegrity®

IMPECCABLE
SKIN
SUNSCREEN FOUNDATION

BROAD SPECTRUM SPF 30

SPF
30

NON-NANO ZINC OXIDE

MEDIUM COVERAGE CC CREAM
SATIN FINISH

Peptides & Vitamins C + E
Blue Light Protection
Oil Free | Vegan | Reef Friendly

NET WT 2 OZ (56.7 g)

PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Tan
PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Tan

PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Bronze

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sun
tegrity®

IMPECCABLE
SKIN
SUNSCREEN FOUNDATION

BROAD SPECTRUM SPF 30

SPF
30

NON-NANO ZINC OXIDE

MEDIUM COVERAGE CC CREAM
SATIN FINISH

Peptides & Vitamins C + E
Blue Light Protection
Oil Free | Vegan | Reef Friendly

NET WT 2 OZ (56.7 g)

PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Bronze
PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Bronze

PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Nude

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sun
tegrity®

IMPECCABLE
SKIN
SUNSCREEN FOUNDATION

BROAD SPECTRUM SPF 30

SPF
30

NON-NANO ZINC OXIDE

MEDIUM COVERAGE CC CREAM
SATIN FINISH

Peptides & Vitamins C + E
Blue Light Protection
Oil Free | Vegan | Reef Friendly

NET WT 2 OZ (56.7 g)

PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Nude
PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Nude

PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Mocha

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sun
tegrity®

IMPECCABLE
SKIN
SUNSCREEN FOUNDATION

BROAD SPECTRUM SPF 30

SPF
30

NON-NANO ZINC OXIDE

MEDIUM COVERAGE CC CREAM
SATIN FINISH

Peptides & Vitamins C + E
Blue Light Protection
Oil Free | Vegan | Reef Friendly

NET WT 2 OZ (56.7 g)

PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Mocha
PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Mocha

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ef9a935e-31b7-402c-a66c-716cdfe4f126Product name920241218
115c5bd2-98e1-4a98-8292-90803ca7e851Product name120220127

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69949-151-01IMPECCABLE SKIN - IVORY56.7 g in 1 TUBECREAM56.73
69949-152-01IMPECCABLE SKIN - BUFF56.7 g in 1 TUBECREAM56.73
69949-153-01IMPECCABLE SKIN - SAND56.7 g in 1 TUBECREAM56.73
69949-154-01IMPECCABLE SKIN - TAN56.7 g in 1 TUBECREAM56.73
69949-155-01IMPECCABLE SKIN - BRONZE56.7 g in 1 TUBECREAM56.73
69949-156-01IMPECCABLE SKIN - NUDE56.7 g in 1 TUBECREAM56.73
69949-157-01IMPECCABLE SKIN - MOCHA56.7 g in 1 TUBECREAM56.73

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69949-151IMPECCABLE SKIN - IVORY (ZINC OXIDE) CREAM IMPECCABLE SKIN - BUFF (ZINC OXIDE) CREAM IMPECCABLE SKIN - SAND (ZINC OXIDE) CREAM IMPECCABLE SKIN - TAN (ZINC OXIDE) CREAM IMPECCABLE SKIN - BRONZE (ZINC OXIDE) CREAM IMPECCABLE SKIN - NUDE (ZINC OXIDE) CREAM IMPECCABLE SKIN - MOCHA (ZINC OXIDE) CREAM [SYNCHRONICITY SPA, INC. DBA SUNTEGRITY]3Current NDC, Legacy NDC, 1 package rows20241127_98a7896e-4b03-4184-ac2e-6b49e47c0bc4.zip
69949-152IMPECCABLE SKIN - IVORY (ZINC OXIDE) CREAM IMPECCABLE SKIN - BUFF (ZINC OXIDE) CREAM IMPECCABLE SKIN - SAND (ZINC OXIDE) CREAM IMPECCABLE SKIN - TAN (ZINC OXIDE) CREAM IMPECCABLE SKIN - BRONZE (ZINC OXIDE) CREAM IMPECCABLE SKIN - NUDE (ZINC OXIDE) CREAM IMPECCABLE SKIN - MOCHA (ZINC OXIDE) CREAM [SYNCHRONICITY SPA, INC. DBA SUNTEGRITY]3Current NDC, Legacy NDC, 1 package rows20241127_98a7896e-4b03-4184-ac2e-6b49e47c0bc4.zip
69949-153IMPECCABLE SKIN - IVORY (ZINC OXIDE) CREAM IMPECCABLE SKIN - BUFF (ZINC OXIDE) CREAM IMPECCABLE SKIN - SAND (ZINC OXIDE) CREAM IMPECCABLE SKIN - TAN (ZINC OXIDE) CREAM IMPECCABLE SKIN - BRONZE (ZINC OXIDE) CREAM IMPECCABLE SKIN - NUDE (ZINC OXIDE) CREAM IMPECCABLE SKIN - MOCHA (ZINC OXIDE) CREAM [SYNCHRONICITY SPA, INC. DBA SUNTEGRITY]3Current NDC, Legacy NDC, 1 package rows20241127_98a7896e-4b03-4184-ac2e-6b49e47c0bc4.zip
69949-154IMPECCABLE SKIN - IVORY (ZINC OXIDE) CREAM IMPECCABLE SKIN - BUFF (ZINC OXIDE) CREAM IMPECCABLE SKIN - SAND (ZINC OXIDE) CREAM IMPECCABLE SKIN - TAN (ZINC OXIDE) CREAM IMPECCABLE SKIN - BRONZE (ZINC OXIDE) CREAM IMPECCABLE SKIN - NUDE (ZINC OXIDE) CREAM IMPECCABLE SKIN - MOCHA (ZINC OXIDE) CREAM [SYNCHRONICITY SPA, INC. DBA SUNTEGRITY]3Current NDC, Legacy NDC, 1 package rows20241127_98a7896e-4b03-4184-ac2e-6b49e47c0bc4.zip
69949-155IMPECCABLE SKIN - IVORY (ZINC OXIDE) CREAM IMPECCABLE SKIN - BUFF (ZINC OXIDE) CREAM IMPECCABLE SKIN - SAND (ZINC OXIDE) CREAM IMPECCABLE SKIN - TAN (ZINC OXIDE) CREAM IMPECCABLE SKIN - BRONZE (ZINC OXIDE) CREAM IMPECCABLE SKIN - NUDE (ZINC OXIDE) CREAM IMPECCABLE SKIN - MOCHA (ZINC OXIDE) CREAM [SYNCHRONICITY SPA, INC. DBA SUNTEGRITY]3Current NDC, Legacy NDC, 1 package rows20241127_98a7896e-4b03-4184-ac2e-6b49e47c0bc4.zip
69949-156IMPECCABLE SKIN - IVORY (ZINC OXIDE) CREAM IMPECCABLE SKIN - BUFF (ZINC OXIDE) CREAM IMPECCABLE SKIN - SAND (ZINC OXIDE) CREAM IMPECCABLE SKIN - TAN (ZINC OXIDE) CREAM IMPECCABLE SKIN - BRONZE (ZINC OXIDE) CREAM IMPECCABLE SKIN - NUDE (ZINC OXIDE) CREAM IMPECCABLE SKIN - MOCHA (ZINC OXIDE) CREAM [SYNCHRONICITY SPA, INC. DBA SUNTEGRITY]3Current NDC, Legacy NDC, 1 package rows20241127_98a7896e-4b03-4184-ac2e-6b49e47c0bc4.zip
69949-157IMPECCABLE SKIN - IVORY (ZINC OXIDE) CREAM IMPECCABLE SKIN - BUFF (ZINC OXIDE) CREAM IMPECCABLE SKIN - SAND (ZINC OXIDE) CREAM IMPECCABLE SKIN - TAN (ZINC OXIDE) CREAM IMPECCABLE SKIN - BRONZE (ZINC OXIDE) CREAM IMPECCABLE SKIN - NUDE (ZINC OXIDE) CREAM IMPECCABLE SKIN - MOCHA (ZINC OXIDE) CREAM [SYNCHRONICITY SPA, INC. DBA SUNTEGRITY]3Current NDC, 1 package rows20241127_98a7896e-4b03-4184-ac2e-6b49e47c0bc4.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 41 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69949-15169949-151-01
69949-15269949-152-01
69949-15369949-153-01
69949-15469949-154-01
69949-15569949-155-01
69949-15669949-156-01
69949-15769949-157-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 6 · 238 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
C13-15 ALKANE114P5I43UJIACT
GLYCERINPDC6A3C0OXIACT
LAUROYL LYSINE113171Q70BIACT
POLYGLYCERYL-2 OLEATE5759J47SAMIACT
POLYHYDROXYSTEARIC ACID STEARATE8KQ7I65XZEIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
STEARALKONIUM HECTORITEOLX698AH5PIACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458IACT
DIPALMITOYL HYDROXYPROLINEE6AHA53N1HIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
TOCOPHEROLR0ZB2556P8IACT
EUROPEAN ELDERBERRYBQY1UBX046IACT
KAPPAPHYCUS ALVAREZIIT479H08K2OIACT
TARA SPINOSA FRUIT PODEXY4496LWDIACT
MELANIN SYNTHETIC (TYROSINE, PEROXIDE)O0CV1RMR44IACT
.ALPHA.-BISABOLOL, (+/-)-36HQN158VCIACT
HYALURONIC ACIDS270N0TRQYIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
OMEGA-3 FATTY ACIDS71M78END5SIACT
POLYGLYCERYL-2 STEARATE253MC0P0YVIACT
BIFIDOBACTERIUM ANIMALIS LACTIS5307V7XW8IIACT
COCONUT3RT3536DHYIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SODIUM CHLORIDE451W47IQ8XIACT
PROPYLENE CARBONATE8D08K3S51EIACT
ISOPROPYL TITANIUM TRIISOSTEARATE949E3KBJ1IIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
ZINC OXIDESOI2LOH54ZACTIB
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
C13-15 ALKANE114P5I43UJIACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IMPECCABLE SKIN - IVORYZINC OXIDESynchronicity Spa, Inc. DBA Suntegrity98a7896e-4b03-4184-ac2e-6b49e47c0bc42024-11-21WarningsExact identifier
ndc (package): 69949-152-01
ndc (package): 69949-154-01
ndc (package): 69949-155-01
ndc (package): 69949-151-01
ndc (package): 69949-156-01
ndc (package): 69949-153-01
ndc (package): 69949-157-01
ndc (product): 69949-152
ndc (product): 69949-157
ndc (product): 69949-151
ndc (product): 69949-156
ndc (product): 69949-154
ndc (product): 69949-153
ndc (product): 69949-155
ndc11 (package): 69949015601
ndc11 (package): 69949015101
ndc11 (package): 69949015301
ndc11 (package): 69949015401
ndc11 (package): 69949015201
ndc11 (package): 69949015701
ndc11 (package): 69949015501
spl id: f0219616-bbcb-4d7e-a1f7-0cbc2cf6efe9
spl set id: 98a7896e-4b03-4184-ac2e-6b49e47c0bc4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.