ULTRA CC RADIANT FOUNDATION BROAD SPECTRUM SPF 17 WARM-MEDIUM- zinc oxide cream 
Pacifica Beauty, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Ultra CC Radiant Foundation Broad spectrum SPF 17 Warm-Medium

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.

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 Warm-Medium Label

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

ULTRA CC RADIANT FOUNDATION BROAD SPECTRUM SPF 17 WARM-MEDIUM 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61197-303
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID11.4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
COCONUT WATER (UNII: 267F5Y81NT)  
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61197-303-0030 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/09/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02002/09/2023
Labeler - Pacifica Beauty, LLC (868275517)
Establishment
NameAddressID/FEIBusiness Operations
Columbia Cosmetics Manufacturers, Inc.068267863manufacture(61197-303)

Revised: 2/2023
Document Id: f44fdfeb-4355-5884-e053-2a95a90ae231
Set id: f44fdfeb-4354-5884-e053-2a95a90ae231
Version: 1
Effective Time: 20230209
 
Pacifica Beauty, LLC