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-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 (Safflower) 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)

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - cool/deep

PACIFICA ®
100% VEGAN • CRUELTY-FREE

ULTRA
CC
CREAM
RADIANT
FOUNDATION

broad spectrum
SPF 17

moisture rich
color correcting
makeup + skincare

with coconut water

1 fl oz • 30 mL

Principal Display Panel - 30 mL Bottle Box - cool/deep

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - warm/tan

PACIFICA ®
100% VEGAN • CRUELTY-FREE

ULTRA
CC
CREAM
RADIANT
FOUNDATION

broad spectrum
SPF 17

moisture rich
color correcting
makeup + skincare

with coconut water

1 fl oz • 30 mL

Principal Display Panel - 30 mL Bottle Box - warm/tan

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - warm/medium

PACIFICA ®
100% VEGAN • CRUELTY-FREE

ULTRA
CC
CREAM
RADIANT
FOUNDATION

broad spectrum
SPF 17

moisture rich
color correcting
makeup + skincare

with coconut water

1 fl oz • 30 mL

Principal Display Panel - 30 mL Bottle Box - warm/medium

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - neutral/fair

PACIFICA ®
100% VEGAN • CRUELTY-FREE

ULTRA
CC
CREAM
RADIANT
FOUNDATION

broad spectrum
SPF 17

moisture rich
color correcting
makeup + skincare

with coconut water

1 fl oz • 30 mL

Principal Display Panel - 30 mL Bottle Box - neutral/fair

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61197-201
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
DIMETHICONE (UNII: 92RU3N3Y1O)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
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 WATER (UNII: 267F5Y81NT)
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)
SAFFLOWER OIL (UNII: 65UEH262IS)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:61197-201-00	1 in 1 BOX	01/01/2021
1		30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/01/2021

PACIFICA ULTRA CC RADIANT FOUNDATION BROAD SPECTRUM SPF 17 WARM TAN
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61197-202
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
DIMETHICONE (UNII: 92RU3N3Y1O)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
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 WATER (UNII: 267F5Y81NT)
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)
SAFFLOWER OIL (UNII: 65UEH262IS)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:61197-202-00	1 in 1 BOX	01/01/2021
1		30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/01/2021

PACIFICA ULTRA CC RADIANT FOUNDATION BROAD SPECTRUM SPF 17 WARM MEDIUM
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61197-203
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
DIMETHICONE (UNII: 92RU3N3Y1O)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
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 WATER (UNII: 267F5Y81NT)
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)
SAFFLOWER OIL (UNII: 65UEH262IS)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:61197-203-00	1 in 1 BOX	01/01/2021
1		30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/01/2021

PACIFICA ULTRA CC RADIANT FOUNDATION BROAD SPECTRUM SPF 17 NEUTRAL FAIR
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61197-204
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
DIMETHICONE (UNII: 92RU3N3Y1O)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
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 WATER (UNII: 267F5Y81NT)
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)
SAFFLOWER OIL (UNII: 65UEH262IS)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:61197-204-00	1 in 1 BOX	01/01/2021
1		30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/01/2021

Labeler - Pacifica Beauty LLC. (058549421)

Name	Address	ID/FEI	Business Operations
Establishment
Sun Deep Inc.		189788201	manufacture(61197-201, 61197-202, 61197-203, 61197-204)

PACIFICA ® ULTRA CC RADIANT FOUNDATION broad spectrum SPF 17

Active ingredient

Purpose

Uses

Warnings

Directions

Inactive ingredients

Other information

Questions or comments?

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - cool/deep

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - warm/tan

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - warm/medium

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - neutral/fair