FDA.reportPublic FDA data

Ultra CC Radiant Foundation Broad Spectrum SPF 17 Warm-Medium

Manufacturer
Pacifica Beauty, LLC | Columbia Cosmetics Manufacturers, Inc.
Effective date
2023-02-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:36:57

Label at a glance#

ProductUltra CC Radiant Foundation Broad Spectrum SPF 17 Warm-Medium
Active ingredientSALICYLIC ACID
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, especi...

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

Active ingredient Purpose

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 11.4% Sunscreen

Uses

OTC - PURPOSE 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.

INDICATIONS & USAGE SECTION

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.

Do not use

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

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

STOP USE AND ASK A DOCTOR

OTC - STOP USE SECTION

STOP USE AND ASK A DOCTOR IF RASH OCCURS.

Keep out of reach of children

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 (Saffower) 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)

Ultra CC Radiant Foundation Broad Spectrum SPF 17 Warm-Medium Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ultra CC Radiant Foundation Broad Spectrum SPF 17 Warm-Medium LabelUltra CC Radiant Foundation Broad Spectrum SPF 17 Warm-Medium Label

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61197-30361197-303-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICAV8A1AW0880IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
HYALURONATE SODIUMYSE9PPT4THIACT
COCONUT WATER267F5Y81NTIACT
WITHANIA SOMNIFERA ROOTV038D626IFIACT
SAFFLOWER OIL65UEH262ISIACT
MACROCYSTIS PYRIFERAK31S3OG5C4IACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
.ALPHA.-AMYLCINNAMALDEHYDEWC51CA3418IACT
SALICYLIC ACIDO414PZ4LPZACTIB
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETEARYL OLIVATE58B69Q84JOIACT
DIMETHICONE92RU3N3Y1OIACT
SORBITAN OLIVATEMDL271E3GRIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM DEHYDROACETATE8W46YN971GIACT
SODIUM BENZOATEOJ245FE5EUIACT
LINALOOL, (+/-)-D81QY6I88EIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
GLYCERINPDC6A3C0OXIACT
HYDROLYZED JOJOBA ESTERS (ACID FORM)UDR641JW8WIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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
29910c3d-a194-e2ad-e063-6394a90a5c7bf44fdfeb-4354-5884-e053-2a95a90ae2312024-12-18WarningsExact identifier
spl set id: f44fdfeb-4354-5884-e053-2a95a90ae231

Reported adverse events (FAERS/openFDA)#

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