Label: 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
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Contains inactivated NDC Code(s)
NDC Code(s): 61197-201-00, 61197-202-00, 61197-203-00, 61197-204-00 - Packager: Pacifica Beauty LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated April 11, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
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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
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Directions
- Apply liberally 15 minutes before sun exposure
- Use a water resistant sunscreen if swimming or sweating
- Reapply at least every 2 hours
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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
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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
- 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
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INGREDIENTS AND APPEARANCE
PACIFICA ULTRA CC RADIANT FOUNDATION BROAD SPECTRUM SPF 17 COOL DEEP
zinc oxide creamProduct 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 creamProduct 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 creamProduct 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 creamProduct 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)
