FDA.reportPublic FDA data

PACIFICA ULTRA CC RADIANT FOUNDATION broad spectrum SPF 17

Manufacturer
Pacifica Beauty LLC. | Sun Deep Inc.
Effective date
2022-04-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:49:09

Label at a glance#

ProductPACIFICA ULTRA CC RADIANT FOUNDATION broad spectrum SPF 17 cool deep
Active ingredientZINC OXIDE
Label structure13 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 Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially ...

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 11.4%

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 - WHEN USING SECTION

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

OTC - STOP USE SECTION

STOP USE AND ASK A DOCTOR IF RASH OCCURS

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
  • Sun protection measures.
    Spending time in the sun increases your risk of skin cancer and early skin aging.
    To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeve shirts, pants, hats and sunglasses
  • Children under 6 months : Ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Caprylic/Capric Triglyceride, Sorbitan Sesquioleate, Dimethicone, Potassium Cetyl Phosphate, Glycerin, Silica, Jojoba Esters, Cetearyl Olivate, Sorbitan Olivate, Mica, Citric Acid, Potassium Sorbate, Sodium Dehydroacetate, Sodium Benzoate, Fragrance (All Natural), Sodium Hyaluronate, Cocos Nucifera (Coconut) Water, Withania Somnifera Root Extract, Carthamus Tinctorius (Safflower) Seed Oil, Macrocystis Pyrifera Extract, Linalool, Amyl Cinnamal, Titanium Dioxide CI 77891, Iron Oxides CI 77491, CI 77492, and CI 77499.

Other information

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-888-322-2466 (8am to 5pm Pacific time, Monday-Friday)

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - cool/deep

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACIFICA ®
100% VEGAN • CRUELTY-FREE

ULTRA
CC
CREAM
RADIANT
FOUNDATION

broad spectrum
SPF 17

moisture rich
color correcting
makeup + skincare

with coconut water

1 fl oz • 30 mL

Principal Display Panel - 30 mL Bottle Box - cool/deep
Principal Display Panel - 30 mL Bottle Box - cool/deep

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - warm/tan

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACIFICA ®
100% VEGAN • CRUELTY-FREE

ULTRA
CC
CREAM
RADIANT
FOUNDATION

broad spectrum
SPF 17

moisture rich
color correcting
makeup + skincare

with coconut water

1 fl oz • 30 mL

Principal Display Panel - 30 mL Bottle Box - warm/tan
Principal Display Panel - 30 mL Bottle Box - warm/tan

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - warm/medium

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACIFICA ®
100% VEGAN • CRUELTY-FREE

ULTRA
CC
CREAM
RADIANT
FOUNDATION

broad spectrum
SPF 17

moisture rich
color correcting
makeup + skincare

with coconut water

1 fl oz • 30 mL

Principal Display Panel - 30 mL Bottle Box - warm/medium
Principal Display Panel - 30 mL Bottle Box - warm/medium

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - neutral/fair

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACIFICA ®
100% VEGAN • CRUELTY-FREE

ULTRA
CC
CREAM
RADIANT
FOUNDATION

broad spectrum
SPF 17

moisture rich
color correcting
makeup + skincare

with coconut water

1 fl oz • 30 mL

Principal Display Panel - 30 mL Bottle Box - neutral/fair
Principal Display Panel - 30 mL Bottle Box - neutral/fair

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61197-201-002024-01-30C16284748780-1d6a99b39-ccb4-a426-e053-dadaa90af4c2PACIFICA ® ULTRA CC RADIANT FOUNDATION broad spectrum SPF 17
61197-202-002024-01-30C16284748780-1d6a99b39-ccb4-a426-e053-dadaa90af4c2PACIFICA ® ULTRA CC RADIANT FOUNDATION broad spectrum SPF 17
61197-203-002024-01-30C16284748780-1d6a99b39-ccb4-a426-e053-dadaa90af4c2PACIFICA ® ULTRA CC RADIANT FOUNDATION broad spectrum SPF 17
61197-204-002024-01-30C16284748780-1d6a99b39-ccb4-a426-e053-dadaa90af4c2PACIFICA ® ULTRA CC RADIANT FOUNDATION broad spectrum SPF 17
61197-201-002022-04-11C16284748780-1d6a99b39-ccb4-a426-e053-dadaa90af4c2PACIFICA ® ULTRA CC RADIANT FOUNDATION broad spectrum SPF 17
61197-202-002022-04-11C16284748780-1d6a99b39-ccb4-a426-e053-dadaa90af4c2PACIFICA ® ULTRA CC RADIANT FOUNDATION broad spectrum SPF 17
61197-203-002022-04-11C16284748780-1d6a99b39-ccb4-a426-e053-dadaa90af4c2PACIFICA ® ULTRA CC RADIANT FOUNDATION broad spectrum SPF 17
61197-204-002022-04-11C16284748780-1d6a99b39-ccb4-a426-e053-dadaa90af4c2PACIFICA ® ULTRA CC RADIANT FOUNDATION broad spectrum SPF 17
61197-201-002022-01-28C16284748780-1d6a99b39-ccb4-a426-e053-dadaa90af4c2PACIFICA ® ULTRA CC RADIANT FOUNDATION broad spectrum SPF 17
61197-202-002022-01-28C16284748780-1d6a99b39-ccb4-a426-e053-dadaa90af4c2PACIFICA ® ULTRA CC RADIANT FOUNDATION broad spectrum SPF 17
61197-203-002022-01-28C16284748780-1d6a99b39-ccb4-a426-e053-dadaa90af4c2PACIFICA ® ULTRA CC RADIANT FOUNDATION broad spectrum SPF 17
61197-204-002022-01-28C16284748780-1d6a99b39-ccb4-a426-e053-dadaa90af4c2PACIFICA ® ULTRA CC RADIANT FOUNDATION broad spectrum SPF 17

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61197-201-00PACIFICA ULTRA CC RADIANT FOUNDATION broad spectrum SPF 17 cool deep30 mL in 1 BOTTLE, PUMPCREAM303
61197-201-00PACIFICA ULTRA CC RADIANT FOUNDATION broad spectrum SPF 17 cool deep1 in 1 BOXCREAM13
61197-202-00PACIFICA ULTRA CC RADIANT FOUNDATION broad spectrum SPF 17 warm tan30 mL in 1 BOTTLE, PUMPCREAM303
61197-202-00PACIFICA ULTRA CC RADIANT FOUNDATION broad spectrum SPF 17 warm tan1 in 1 BOXCREAM13
61197-203-00PACIFICA ULTRA CC RADIANT FOUNDATION broad spectrum SPF 17 warm medium1 in 1 BOXCREAM13
61197-203-00PACIFICA ULTRA CC RADIANT FOUNDATION broad spectrum SPF 17 warm medium30 mL in 1 BOTTLE, PUMPCREAM303
61197-204-00PACIFICA ULTRA CC RADIANT FOUNDATION broad spectrum SPF 17 neutral fair1 in 1 BOXCREAM13
61197-204-00PACIFICA ULTRA CC RADIANT FOUNDATION broad spectrum SPF 17 neutral fair30 mL in 1 BOTTLE, PUMPCREAM303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61197-201PACIFICA ULTRA CC RADIANT FOUNDATION BROAD SPECTRUM SPF 17 COOL DEEP (ZINC OXIDE) CREAM PACIFICA ULTRA CC RADIANT FOUNDATION BROAD SPECTRUM SPF 17 WARM TAN (ZINC OXIDE) CREAM PACIFICA ULTRA CC RADIANT FOUNDATION BROAD SPECTRUM SPF 17 WARM MEDIUM (ZINC OXIDE) CREAM PACIFICA ULTRA CC RADIANT FOUNDATION BROAD SPECTRUM SPF 17 NEUTRAL FAIR (ZINC OXIDE) CREAM [PACIFICA BEAUTY LLC.]3Legacy NDC, 2 package rows20220412_ef603375-86cb-4d50-928a-668dd8ae4526.zip
61197-202PACIFICA ULTRA CC RADIANT FOUNDATION BROAD SPECTRUM SPF 17 COOL DEEP (ZINC OXIDE) CREAM PACIFICA ULTRA CC RADIANT FOUNDATION BROAD SPECTRUM SPF 17 WARM TAN (ZINC OXIDE) CREAM PACIFICA ULTRA CC RADIANT FOUNDATION BROAD SPECTRUM SPF 17 WARM MEDIUM (ZINC OXIDE) CREAM PACIFICA ULTRA CC RADIANT FOUNDATION BROAD SPECTRUM SPF 17 NEUTRAL FAIR (ZINC OXIDE) CREAM [PACIFICA BEAUTY LLC.]3Legacy NDC, 2 package rows20220412_ef603375-86cb-4d50-928a-668dd8ae4526.zip
61197-203PACIFICA ULTRA CC RADIANT FOUNDATION BROAD SPECTRUM SPF 17 COOL DEEP (ZINC OXIDE) CREAM PACIFICA ULTRA CC RADIANT FOUNDATION BROAD SPECTRUM SPF 17 WARM TAN (ZINC OXIDE) CREAM PACIFICA ULTRA CC RADIANT FOUNDATION BROAD SPECTRUM SPF 17 WARM MEDIUM (ZINC OXIDE) CREAM PACIFICA ULTRA CC RADIANT FOUNDATION BROAD SPECTRUM SPF 17 NEUTRAL FAIR (ZINC OXIDE) CREAM [PACIFICA BEAUTY LLC.]3Legacy NDC, 2 package rows20220412_ef603375-86cb-4d50-928a-668dd8ae4526.zip
61197-204PACIFICA ULTRA CC RADIANT FOUNDATION BROAD SPECTRUM SPF 17 COOL DEEP (ZINC OXIDE) CREAM PACIFICA ULTRA CC RADIANT FOUNDATION BROAD SPECTRUM SPF 17 WARM TAN (ZINC OXIDE) CREAM PACIFICA ULTRA CC RADIANT FOUNDATION BROAD SPECTRUM SPF 17 WARM MEDIUM (ZINC OXIDE) CREAM PACIFICA ULTRA CC RADIANT FOUNDATION BROAD SPECTRUM SPF 17 NEUTRAL FAIR (ZINC OXIDE) CREAM [PACIFICA BEAUTY LLC.]3Legacy NDC, 2 package rows20220412_ef603375-86cb-4d50-928a-668dd8ae4526.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61197-20161197-201-00
61197-20261197-202-00
61197-20361197-203-00
61197-20461197-204-00

Ingredients#

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

DailyMed ingredient rows page 1 of 3 · 104 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
DIMETHICONE92RU3N3Y1OIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
GLYCERINPDC6A3C0OXIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CETEARYL OLIVATE58B69Q84JOIACT
SORBITAN OLIVATEMDL271E3GRIACT
MICAV8A1AW0880IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM DEHYDROACETATE8W46YN971GIACT
SODIUM BENZOATEOJ245FE5EUIACT
HYALURONATE SODIUMYSE9PPT4THIACT
COCONUT WATER267F5Y81NTIACT
WITHANIA SOMNIFERA ROOTV038D626IFIACT
SAFFLOWER OIL65UEH262ISIACT
MACROCYSTIS PYRIFERAK31S3OG5C4IACT
LINALOOL, (+/-)-D81QY6I88EIACT
.ALPHA.-AMYLCINNAMALDEHYDEWC51CA3418IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
DIMETHICONE92RU3N3Y1OIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
GLYCERINPDC6A3C0OXIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CETEARYL OLIVATE58B69Q84JOIACT
SORBITAN OLIVATEMDL271E3GRIACT
MICAV8A1AW0880IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM DEHYDROACETATE8W46YN971GIACT
SODIUM BENZOATEOJ245FE5EUIACT

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
dc5ce340-9e17-563a-e053-2a95a90a34fbef603375-86cb-4d50-928a-668dd8ae45262022-04-11WarningsExact identifier
spl id: dc5ce340-9e17-563a-e053-2a95a90a34fb
spl set id: ef603375-86cb-4d50-928a-668dd8ae4526

Reported adverse events (FAERS/openFDA)#

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