ULTRA CC RADIANT FOUNDATION BROAD SPECTRUM SPF 17 COOL-DEEP- zinc oxide cream

Ultra CC Radiant Foundation Broad Spectrum SPF 17 Cool-Deep by

Drug Labeling and Warnings

Ultra CC Radiant Foundation Broad Spectrum SPF 17 Cool-Deep by is a Otc medication manufactured, distributed, or labeled by Pacifica Beauty, LLC, Columbia Cosmetics Manufacturers, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient Purpose

Zinc Oxide 11.4% 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.

INDICATIONS & USAGE

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

Do not use on damaged or broken skin.

When using this product

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

STOP USE AND ASK A DOCTOR

STOP USE AND ASK A DOCTOR IF RASH OCCURS.

Keep out of reach of children

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. 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:

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

Protect this product from excessive heat and direct sun.

Questions or comments?

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

Ultra CC Radiant Foundation Broad Spectrum SPF 17 Cool-Deep Label

INGREDIENTS AND APPEARANCE

ULTRA CC RADIANT FOUNDATION BROAD SPECTRUM SPF 17 COOL-DEEP 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61197-300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	11.4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SAFFLOWER OIL (UNII: 65UEH262IS)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
SORBITAN OLIVATE (UNII: MDL271E3GR)
MICA (UNII: V8A1AW0880)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
SODIUM BENZOATE (UNII: OJ245FE5EU)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCONUT WATER (UNII: 267F5Y81NT)
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIMETHICONE (UNII: 92RU3N3Y1O)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61197-300-00	30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/09/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	02/09/2023

Labeler - Pacifica Beauty, LLC (868275517)

Establishment
Name	Address	ID/FEI	Business Operations
Columbia Cosmetics Manufacturers, Inc.		068267863	manufacture(61197-300)