PACIFICA CC BROAD SPECTRUM SPF 17 MEDIUM- zinc oxide cream

Pacifica CC broad spectrum SPF 17 MEDIUM by

Drug Labeling and Warnings

Pacifica CC broad spectrum SPF 17 MEDIUM by is a Otc medication manufactured, distributed, or labeled by Pacifica Beauty, LLC, Columbia Cosmetics Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

ZInc Oxide 11.4%

Purpose

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.

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:

• 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-sleeved 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, 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:

INGREDIENTS AND APPEARANCE

PACIFICA CC BROAD SPECTRUM SPF 17 MEDIUM 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61197-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	114 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61197-001-00	1 in 1 BOX	11/21/2013
1		30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/21/2013

Labeler - Pacifica Beauty, LLC (058549421)

Establishment
Name	Address	ID/FEI	Business Operations
Columbia Cosmetics Manufacturing, Inc.		068267863	manufacture(61197-001)