PACIFICA CC BROAD SPECTRUM SPF 17 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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Pacifica CC+ CREAM broad spectrum SPF 17 MEDIUM

Drug Facts


Active ingredient

ZInc Oxide 11.4%

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not use

on damaged or broken skin.

When using this product

keep out of eyes. Rinse with water to remove

STOP USE AND ASK A DOCTOR

IF RASH OCCURS

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

- limit time in the sun, especially from 10 a.m. - 2 p.m.

- wear long-sleeved shirts, pants, hats and sunglasses

Inactive ingredients:

water (aqua), caprylic/capric triglyceride, sorbitan sesquioleate, dimethicone, potassium cetyl phosphate, glycerin, silica, jojoba esters, ceteraryl olivate, sorbitan olivate, mica, citric acid, potassium sorbate, sodium dehydroacetate, sodium benzoate, fragrance, 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 CI77499

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)

Package Labeling:

image description

PACIFICA CC BROAD SPECTRUM SPF 17 MEDIUM 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61197-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE114 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
GLYCERIN (UNII: PDC6A3C0OX)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ETHYL JOJOBATE (UNII: 2351QH8W1N)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
MICA (UNII: V8A1AW0880)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
COCONUT JUICE (UNII: AMN6S4M09G)  
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61197-001-001 in 1 BOX11/21/2013
130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/21/2013
Labeler - Pacifica Beauty, LLC (058549421)
Establishment
NameAddressID/FEIBusiness Operations
Columbia Cosmetics Manufacturing, Inc.068267863manufacture(61197-001)

Revised: 12/2019
Document Id: 995b6573-27fe-2773-e053-2a95a90a90af
Set id: 3336d676-5ad9-4f8e-bb71-fa14a6b3e252
Version: 3
Effective Time: 20191210
 
Pacifica Beauty, LLC