Label: PACIFICA CC BROAD SPECTRUM SPF 17 MEDIUM- zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 61197-001-00 - 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 December 10, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Uses
- 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
- 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
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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
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- Package Labeling:
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INGREDIENTS AND APPEARANCE
PACIFICA CC BROAD SPECTRUM SPF 17 MEDIUM
zinc oxide creamProduct 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)
