Label: MARY KAY FOUNDATION PRIMER- avobenzone, homosalate, octisalate, octocrylene gel
- NDC Code(s): 51531-0850-0, 51531-0850-1
- 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 October 10, 2022
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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
- Inactive ingredients
- Other information
- Questions or comments?
- Principal Display Panel - 29 mL carton
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INGREDIENTS AND APPEARANCE
MARY KAY FOUNDATION PRIMER
avobenzone, homosalate, octisalate, octocrylene gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51531-0850 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.5 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 9 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 3 g in 100 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) ISODODECANE (UNII: A8289P68Y2) DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF) VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) POLYESTER-7 (UNII: 0841698D2F) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) TRIBEHENIN (UNII: 8OC9U7TQZ0) DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O) PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51531-0850-1 1 in 1 CARTON 03/01/2012 1 29 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:51531-0850-0 0.5 mL in 1 PACKET; Type 0: Not a Combination Product 03/01/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 03/01/2012 Labeler - Mary Kay Inc. (049994452) Establishment Name Address ID/FEI Business Operations Mary Kay Inc. 103978839 manufacture(51531-0850)