Label: ULTRA CC RADIANT FOUNDATION BROAD SPECTRUM SPF 17 NEUTRAL-FAIR- zinc oxide cream
- NDC Code(s): 61197-302-00
- Packager: Pacifica Beauty, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 February 9, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient Purpose
- Uses
- INDICATIONS & USAGE
- Warnings
- Do not use
- When using this product
- STOP USE AND ASK A DOCTOR
- Keep out of reach of children
-
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 (Saffower) 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?
- Ultra CC Radiant Foundation Broad Spectrum SPF 17 Neutral-Fair Label
-
INGREDIENTS AND APPEARANCE
ULTRA CC RADIANT FOUNDATION BROAD SPECTRUM SPF 17 NEUTRAL-FAIR
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61197-302 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 11.4 g in 100 mL Inactive Ingredients Ingredient Name Strength LINALOOL, (+/-)- (UNII: D81QY6I88E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CETEARYL OLIVATE (UNII: 58B69Q84JO) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) HYALURONATE SODIUM (UNII: YSE9PPT4TH) WITHANIA SOMNIFERA ROOT (UNII: V038D626IF) MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W) SORBITAN OLIVATE (UNII: MDL271E3GR) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) WATER (UNII: 059QF0KO0R) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) MICA (UNII: V8A1AW0880) COCONUT WATER (UNII: 267F5Y81NT) SAFFLOWER OIL (UNII: 65UEH262IS) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61197-302-00 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 02/09/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 02/09/2023 Labeler - Pacifica Beauty, LLC (868275517) Establishment Name Address ID/FEI Business Operations Columbia Cosmetics Manufacturers, Inc. 068267863 manufacture(61197-302)
