Label: MARY KAY CC CREAM SUNSCREEN BROAD SPECTRUM SPF 15 DEEP- homosalate, octinoxate, oxybenzone cream
- NDC Code(s): 51531-2825-1, 51531-2825-3
- Packager: Mary Kay Inc.
- 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 July 24, 2023
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- 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 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
- Other information
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Inactive ingredients
water, cyclopentasiloxane, butylene glycol, glycerin, PEG-9 polydimethylsiloxyethyl dimethicone, niacinamide, mica, PEG-9 dimethicone, magnesium sulfate, ascorbyl glucoside, silybum marianum fruit extract, tocopheryl acetate, salix nigra (willow) bark extract, salicylic acid, adenosine, dimethicone/PEG-10/15 crosspolymer, disodium stearoyl glutamate, xanthan gum, dipropylene glycol, disodium EDTA, cyclohexasiloxane, sodium citrate, tocopherol, sorbic acid, sodium benzoate, benzyl alcohol, aluminum hydroxide, titanium dioxide, iron oxides
- Questions or comments?
- Principal Display Panel - 29 mL carton
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INGREDIENTS AND APPEARANCE
MARY KAY CC CREAM SUNSCREEN BROAD SPECTRUM SPF 15 DEEP
homosalate, octinoxate, oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51531-2825 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 5 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6.5 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 1.2 g in 100 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS) WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) NIACINAMIDE (UNII: 25X51I8RD4) MICA (UNII: V8A1AW0880) PEG-9 DIMETHICONE (400 CST) (UNII: 9OZ27X065D) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW) MILK THISTLE (UNII: U946SH95EE) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SALIX NIGRA BARK (UNII: QU52J3A5B3) SALICYLIC ACID (UNII: O414PZ4LPZ) ADENOSINE (UNII: K72T3FS567) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) XANTHAN GUM (UNII: TTV12P4NEE) DIPROPYLENE GLYCOL (UNII: E107L85C40) EDETATE DISODIUM (UNII: 7FLD91C86K) CYCLOMETHICONE 6 (UNII: XHK3U310BA) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) TOCOPHEROL (UNII: R0ZB2556P8) SORBIC ACID (UNII: X045WJ989B) SODIUM BENZOATE (UNII: OJ245FE5EU) BENZYL ALCOHOL (UNII: LKG8494WBH) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51531-2825-1 1 in 1 CARTON 02/16/2014 1 29 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:51531-2825-3 1 mL in 1 PACKET; Type 0: Not a Combination Product 02/16/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 02/16/2014 Labeler - Mary Kay Inc. (049994452) Establishment Name Address ID/FEI Business Operations Englewood Lab Inc. 172198223 manufacture(51531-2825) Establishment Name Address ID/FEI Business Operations Mary Kay Inc. 103978839 manufacture(51531-2825)