Label: ULTRA CC RADIANT FOUNDATION BROAD SPECTRUM SPF 17 WARM-MEDIUM- zinc oxide cream
- NDC Code(s): 61197-303-00
- 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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- 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
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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-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 (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 Warm-Medium Label
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INGREDIENTS AND APPEARANCE
ULTRA CC RADIANT FOUNDATION BROAD SPECTRUM SPF 17 WARM-MEDIUM
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61197-303 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 11.4 g in 100 mL Inactive Ingredients Ingredient Name Strength MICA (UNII: V8A1AW0880) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) HYALURONATE SODIUM (UNII: YSE9PPT4TH) COCONUT WATER (UNII: 267F5Y81NT) WITHANIA SOMNIFERA ROOT (UNII: V038D626IF) SAFFLOWER OIL (UNII: 65UEH262IS) MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CETEARYL OLIVATE (UNII: 58B69Q84JO) DIMETHICONE (UNII: 92RU3N3Y1O) SORBITAN OLIVATE (UNII: MDL271E3GR) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) SODIUM BENZOATE (UNII: OJ245FE5EU) LINALOOL, (+/-)- (UNII: D81QY6I88E) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) GLYCERIN (UNII: PDC6A3C0OX) HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61197-303-00 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(61197-303)