PACIFICA ULTRA CC RADIANT FOUNDATION BROAD SPECTRUM SPF 17 COOL DEEP- zinc oxide cream PACIFICA ULTRA CC RADIANT FOUNDATION BROAD SPECTRUM SPF 17 WARM TAN- zinc oxide cream PACIFICA ULTRA CC RADIANT FOUNDATION BROAD SPECTRUM SPF 17 WARM MEDIUM- zinc oxide cream PACIFICA ULTRA CC RADIANT FOUNDATION BROAD SPECTRUM SPF 17 NEUTRAL FAIR- zinc oxide cream

PACIFICA ULTRA CC RADIANT FOUNDATION broad spectrum SPF 17 by

Drug Labeling and Warnings

PACIFICA ULTRA CC RADIANT FOUNDATION broad spectrum SPF 17 by is a Otc medication manufactured, distributed, or labeled by Pacifica Beauty LLC., Sun Deep Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 - 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/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 - 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

INGREDIENTS AND APPEARANCE

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

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)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

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)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

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)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

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)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2021

Labeler - Pacifica Beauty LLC. (058549421)

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